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This is an example showing the report table, trial design, and results from a study's in vitro bacterial reverse mutation test

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using 4 different amino acid-requiring strains of S. typhimurium and 1 strain of E. coli to detect point mutations.
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Expand
titleReport Table for Example Study 8325064

This table shows the assay results for study 8325064, test article TA1, and 3 strains of salmonella (TA98, TA100, and TA1535) at varying concentrations. For ease of reference, each row has been labeled in the right-hand margin with the applicant-defined trial set label (e.g., SetA).  For brevity, the remaining tables (e.g., additional strains, samples prepared without metabolic activation) are not included.

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This example Trial Summary (TS) dataset

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,
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shows many informational fields
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that provide context at the study level.   

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Dataset wrap
Rowcaps
Rows 1-2:

Show 2 records for TSPARMCD = "GLPTYP", using TSSEQ to indicate multiple records,

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since both GLP types apply for this  study. 

Row 8:Shows that the applicant's study reference ID is not applicable.
Rows 9-12:Show that TSGRPID has been used to link records (name, location, country) related to the test facility (TSGRPID=1). The study director is associated with the test facility.
Rows 14-16:

Show that TSGRPID (TSGRPID=4) has been used to link the information on the testing guideline followed on this study (TSTGDNAM, TSTGDORG, TSTGDVER).  

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Rows 19, 25:

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Show that this study includes 2 different species of bacteria.
Rows 18-23:Show that TSGRPID (TSGRPID = 2) has been used to link the information for 1 species (salmonella) with 4 different strains and the cell line that are tested in this  study.
Rows 25-26:

Show that TSGRPID (TSGRPID = 3) has been used to link the information for 1 species (E. coli) with the strain and cell line that is tested in this study.

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Dataset2
Row

STUDYID

GNTXAID

DOMAIN

TSSEQ

TSGRPID

TSPARMCD

TSPARM

TSVAL

TSVALNF

18325064AmesTS1
GLPTYPGood Laboratory Practice TypeFDA
28325064AmesTS2
GLPTYPGood Laboratory Practice TypeOECD
38325064AmesTS1
STSTDTCStudy Start Date2015-07-29
48325064AmesTS1
STITLEStudy Title

The Bacterial Reverse Mutation Test, Study 8325064-1


58325064AmesTS1
SNDIGVERSEND Implementation Guide VersionTOBACCO IMPLEMENTATION GUIDE VERSION 1.0
68325064AmesTS1
SNDCTVERSEND Controlled Terminology VersionSEND Terminology 2021-09-30
78325064AmesTS1
SAPPLCNTApplicant OrganizationExample Applicant Inc.
88325064AmesTS1
SPREFIDApplicant's Study Reference ID
NOT APPLICABLE
98325064AmesTS11TSTFNAMTest Facility NameExample Tox Lab Name
108325064AmesTS11TSTFLOCTest Facility Location10 Somewhere Street, Montgomery, AL 10000
118325064AmesTS11TFCNTRYTest Facility CountryUSA
128325064AmesTS11STDIRStudy DirectorDr. R. Smith
138325064AmesTS1
GLPFLGLP FlagN
148325064AmesTS14TSTGDNAMTesting Guideline NameTest NO. 471
158325064AmesTS14TSTGDORGTesting Guideline OrganizationOECD
168325064AmesTS14TSTGDVERTesting Guideline Version2020-06-29
178325064AmesTS1
SSTYPStudy TypeGENOTOXICITY IN VITRO
188325064AmesTS1
SSSTYPStudy Sub TypeBACTERIAL REVERSE MUTATION TEST
198325064AmesTS12

SPECIES

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Species

SALMONELLA TYPHIMURIUM

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208325064AmesTS12STRAINStrain/SubstrainTA98
218325064AmesTS12STRAINStrain/SubstrainTA100
228325064AmesTS12STRAINStrain/SubstrainTA1535
238325064AmesTS12STRAINStrain/SubstrainTA1537
248325064AmesTS12CELLLNCell Line

258325064AmesTS13SPECIESSpecies

Escherichia coli

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268325064AmesTS13STRAINStrain/SubstrainWP2 uvrA pKM101
278325064AmesTS13CELLLNCell Line

This example Trial Set (TX) dataset shows information about the test conditions for SetA and SetR in this study. For brevity, the dataset does not show information for SetF, SetG, or any other sets. 

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A fully formed TX dataset for this example study would include information about the test conditions for all sets. 


Dataset wrap
Nametx
Rowcaps
Rows 1-14:Show trial set SetSTM, with trial set parameters and trial set values that comprise the test conditions for all data for the species S. typhimurium
Rows 15, 24, 33, 42:Show that SetA, SetF, SetG, and SetR each have a parent set code of SetSTM.  As a child set of SetSTM, each of these sets inherit the test conditions of SetSTM.
Rows 15-23:

Show trial set parameters and trial set values that comprise the test conditions for the set SetA. SetA is the data for the vehicle control (i.e., Strain of TA98, vehicle control with concentration value of 0). SetA is associated with the first row, labeled "SetA", in the report table for example study 8325064.

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Rows 24-32:

Show trial set parameters and trial set values that comprise the test conditions for the set SetF. SetF is the data for the strain of TA98 with a concentration value of 500 µg/plate. SetF is associated with the sixth row, labeled "SetF", in the report table for example study 8325064.

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Rows 33-41:Show trial set parameters and trial set values that comprise the test conditions for the set SetG. SetG is the data for the strain of TA98 with a concentration value of 1600 µg/plate. SetG is associated with the seventh row, labeled "SetG", in the report table for example study 8325064.
Rows 42-50:Show trial set parameters and trial set values that comprise the test conditions for the set SetR. SetR is the data for the strain of TA100, positive control with a concentration value of 2 µg/plate. SetR is associated with the eighteenth row, labeled "SetR", in the report table for example study 8325064.
Row 10:

SPTOBID (Applicant-Defined Tobacco Product ID) is used to uniquely identify the tobacco product. The value of SPTOBID, in this case CIG01a, matches the value for SPTOBID in all the TOPARMCD-TOVAL pairs in the Tobacco Product Identifiers and Descriptors (TO) dataset example in Section 3.1.2, Product Design Parameters and Conformance Testing, Example 1. The TOPARMCD-TOVAL pairs identify this unique product, CIG01a.

The TO domain is described in Section 2.8.8.1, Tobacco Product Identifiers and Descriptors (TO).

Row 13:

SPDEVID is the applicant-defined device identifier that is used to uniquely identify the device in the Unique Device Identification (DI) dataset (see also Section 2.8.9.7, SEND Device Identifiers (DI)). The value of SPDEVID, in this case PUFFMASTER3K, matches the value of SPDEVID in all the DIPARMCD-DIVAL pairs that identify this unique device in the DI dataset. This is shown in the DI dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 1.

Row 14:

Shows a value for DUREFID. DUREFID serves as a link to the Device-In Use Properties (DU) domain (see also Section 2.8.9.8, SEND Device-In-Use (DU)), where a matching value of DUREFID indicates parameters of the smoking regimen performed by the smoking machine, as in the DU dataset in Section 3.1.3.2, HPHCs, Other Constituents, and Smoking/Vaping Regimens, Example 2.

Dataset2

 

RowSTUDYIDGNTXAIDDOMAINSETCDSETTXSEQTXPARMCDTXPARMTXVAL
18325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM

1

SPECIESSpeciesSALMONELLA TYPHIMURIUM
28325064AmesTXSetSTM

SALMONELLA TYPHIMURIUM

2TRTDMINIn vitro Treatment Duration Minimum71.5
38325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM3TRTDTRGIn vitro Treatment Duration Target72
48325064AmesTXSetSTMSALMONELLA TYPHIMURIUM4TRTDMAXIn vitro Treatment Duration Maximum72.5
58325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM

5TRTDUIn vitro Treatment Duration UnitHOURS
68325064AmesTXSetSTMSALMONELLA TYPHIMURIUM6INCBTMPIncubation Temperature37
78325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM7INCBTMPUIncubation Temperature UnitC
88325064AmesTXSetSTM

SALMONELLA TYPHIMURIUM

8HUMIDAtmospheric Relative Humidity Percent50
98325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM9ATMCO2Atmospheric CO2 Percent5
108325064AmesTXSetSTMSALMONELLA TYPHIMURIUM10SPTOBID

Applicant-defined tobacco identifier

CIG01a
118325064AmesTX

SetSTM

SALMONELLA TYPHIMURIUM

11EXPTYP

Exposure Type

Submerged
128325064AmesTXSetSTMSALMONELLA TYPHIMURIUM12SAMTYP

Sample Type

Total Particulate Matter in PBS
138325064AmesTXSetSTM

SALMONELLA TYPHIMURIUM

13SPDEVIDApplicant-defined device identifierPUFFMASTER3K
148325064AmesTXSetSTMSALMONELLA TYPHIMURIUM14DUREFIDSmoke RegimenNON-INTENSE REGIMEN
158325064AmesTXSetAA-TA98-C015PSETCDParent Set CodeSetSTM
168325064AmesTXSetAA-TA98-C015STRAINStrain/SubstrainTA98
178325064AmesTX

SetA

A-TA98-C016METACTMetabolic ActivationNOT APPLICABLE
188325064AmesTX

SetA

A-TA98-C017METACTFLY/N presence of metabolic activationN
198325064AmesTXSetAA-TA98-C018INTRVN

Name of the intervention article

TA1
208325064AmesTXSetAA-TA98-C019ITVTYPE

Type of intervention article

Vehicle Control
218325064AmesTXSetAA-TA98-C020ITVCONCConcentration of intervention article0
228325064AmesTXSetAA-TA98-C021ITVCONCUConcentration Unitug/plate
238325064AmesTXSetAA-TA98-C022TRTVTreatment VehicleDMSO
248325064AmesTXSetF

F-TA98-C500

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PSETCDParent Set CodeSetSTM
258325064AmesTXSetFF-TA98-C50023STRAINStrain/SubstrainTA98
268325064AmesTXSetFF-TA98-C50024METACTMetabolic ActivationNOT APPLICABLE
278325064AmesTXSetFF-TA98-C50025METACTFLY/N presence of metabolic activationN
288325064AmesTXSetFF-TA98-C50026INTRVN

Name of the intervention article

TA1
298325064AmesTXSetFF-TA98-C50027ITVTYPE

Type of intervention article

Product
308325064AmesTXSetFF-TA98-C50028ITVCONCConcentration of intervention article500
318325064AmesTXSetFF-TA98-C50029ITVCONCUConcentration Unitug/plate
328325064AmesTXSetFF-TA98-C50030TRTVTreatment VehicleDMSO
338325064AmesTXSetGG-TA98-C160031PSETCDParent Set CodeSetSTM
348325064AmesTXSetGG-TA98-C160031STRAINStrain/SubstrainTA98
358325064AmesTXSetGG-TA98-C160032METACTMetabolic ActivationNOT APPLICABLE
368325064AmesTXSetGG-TA98-C160033METACTFLY/N presence of metabolic activationN
378325064AmesTXSetGG-TA98-C160034INTRVN

Name of the intervention article

TA1
388325064AmesTXSetGG-TA98-C160035ITVTYPE

Type of intervention article

Product
398325064AmesTXSetGG-TA98-C160036ITVCONCConcentration of intervention article1600
408325064AmesTXSetGG-TA98-C160037ITVCONCUConcentration Unitug/plate
418325064AmesTXSetGG-TA98-C160038TRTVTreatment VehicleDMSO
428325064AmesTX

SetR

R-TA100-C239PSETCDParent Set CodeSetSTM
438325064AmesTX

SetR

R-TA100-C239STRAINStrain/SubstrainTA100
448325064AmesTX

SetR

R-TA100-C240METACTMetabolic ActivationNOT APPLICABLE
458325064AmesTX

SetR

R-TA100-C241METACTFLY/N presence of metabolic activationN
468325064AmesTX

SetR

R-TA100-C242INTRVN

name of the intervention article

NaN3
478325064AmesTX

SetR

R-TA100-C243ITVTYPE

type of intervention article

Positive Control
488325064AmesTX

SetR

R-TA100-C244ITVCONCConcentration of intervention article2
498325064AmesTX

SetR

R-TA100-C245ITVCONCUConcentration Unitug/plate
508325064AmesTX

SetR

R-TA100-C246TRTVTreatment VehicleDMSO

REFID values are defined by the applicant to uniquely identify the observational unit within an experimental unit. In the simplified diagram of an assay procedure (below), the test tube that contains the possible mutagen is an example of an entity that would have a REFID indicating information at the level of trial set. The petri plate created from that test tube and used to count revertant numbers is an example of an entity that would be at an observational level. 

This picture does not depict the more complicated procedures,

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trial sets, or observational units for the example study. For study 8325064, the applicant chose to define the REFIDs at the trial set level with a single character (e.g., A, F, G, R) and chose to define REFIDs at the observational level based on the location of each tube in 1 of multiple exposure/incubation plates (e.g, 6_1 for plate 6, position 1).


Dataset wrap
Namerelref
Rowcaps
Row 1:

Shows the value of REFID=STM. This REFID refers to the trial set with a SETCD of "SetSTM"

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, as defined in the TX dataset. LEVEL=1 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set.

Rows 1, 2, 8, 12, 16:

Show that the trial set SetSTM is the parent of set codes SetA, SetF, SetG, and SetR.

Row 2:Shows the value of REFID=A. This REFID refers to the trial set with a SETCD of "SetA", as defined in the TX dataset. LEVEL=2 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set.
Rows 3-7:Show the values of 5 observational units (1_1 through 1_5) that are within the parent experimental unit, REFID=A.
Row 8: Shows the value of REFID=F. This REFID refers to the trial set with a SETCD of "SetF", as defined in the TX dataset. LEVEL=2 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set.
Rows 9-11:Show the values of 3 observational units (6_1 through 6_3) that are within the parent experimental unit, REFID=F.
Row 12:Shows the value of REFID=G. This REFID refers to the trial set with a SETCD of "SetG", as defined in the TX dataset. LEVEL=2 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set.
Rows 13-15:Show the values of 3 observational units (7_1 through 7_3) that are within the parent experimental unit, REFID=G.
Row 16:Shows the value of REFID=R. This REFID refers to the trial set with a SETCD of "SetG", as defined in the TX dataset. LEVEL=2 and LVLDESC="TRIAL SET" indicates this identifier relates to the entire trial set.
Rows 17-19:

Show the values of 3 observational units (18_1 through 18_3) that are within the parent experimental unit, REFID=R.

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Dataset2
tableidrelref.xpt

Row

STUDYID

GNTXAID

SETCD

REFID

PARENT

LEVEL

LVLDESC

1

8325064

Ames

SetSTM

STM


1

TRIAL SET

2

8325064

Ames

SetA

A

STM

2

EXPERIMENTAL UNIT/TRIAL SET

3

8325064

Ames

SetA

1_1

A

3

OBSERVATIONAL UNIT

4

8325064

Ames

SetA

1_2

A

3

OBSERVATIONAL UNIT

5

8325064

Ames

SetA

1_3

A

3

OBSERVATIONAL UNIT

6

8325064

Ames

SetA

1_4

A

3

OBSERVATIONAL UNIT

7

8325064

Ames

SetA

1_5

A

3

OBSERVATIONAL UNIT

8

8325064

Ames

SetF

F

STM

2

EXPERIMENTAL UNIT/TRIAL SET

9

8325064

Ames

SetF6_1F

3

OBSERVATIONAL UNIT

10

8325064

Ames

SetF6_2F

3

OBSERVATIONAL UNIT

11

8325064

Ames

SetF

6_3F

3

OBSERVATIONAL UNIT

12

8325064

Ames

SetG

G

STM

2

EXPERIMENTAL UNIT/TRIAL SET

13

8325064

Ames

SetG7_1G

3

OBSERVATIONAL UNIT

14

8325064

Ames

SetG

7_2G

3

OBSERVATIONAL UNIT

15

8325064

Ames

SetG7_3G

3

OBSERVATIONAL UNIT

16

8325064

Ames

SetG

R

STM

2

EXPERIMENTAL UNIT/TRIAL SET

17

8325064

Ames

SetR18_1R

3

OBSERVATIONAL UNIT

18

8325064

Ames

SetR18_2R

3

OBSERVATIONAL UNIT

19

8325064

Ames

SetR18_3R

3

OBSERVATIONAL UNIT

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Dataset wrap
Namegt
Rowcaps
Rows 1-5:Show the number of revertant colonies per plate collected for each of 5 observational units, GTREFID=1_1 through 1_5 (see description in the RELREF dataset).
Rows 6, 7:Show summary values collected (mean, standard deviation) for GTREFID=A that apply to the entire trial set, SetA, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID as shown in the RELREF dataset. 
Rows 8-13:Revertent colonies were counted for each of 3 plates/observational units (GTREFID=6_1 through 6_3) and each value is associated with a record to show a postfix code of "V" (Very thin background bacterial lawn).
Rows 14-16:Show summary values collected (mean, standard deviation, fold increase) for GTREFID=F that apply to the entire trial set, SetF, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the RELREF dataset. 
Rows 17-19:Show 3 plates/observational units (GTREFID=7_1 through 7_3) where no revertant colonies were counted due to too much cytotoxicity and a postfix code of "T".
Rows 20-22:Show the number of revertant colonies per plate collected for each of 3 observational units (GTREFID=18_1 through 18_3).
Rows 23-25:Show summary values collected (mean, standard deviation, fold increase) for GTREFID=R that apply to the entire trial set, SetR, as indicated by LEVEL=1 and LVLDESC=TRIAL SET for this REFID in the RELREF dataset. 
Dataset2
RowSTUDYIDGNTXAIDDOMAINGTSEQGTREFIDGTTESTCDGTTESTGTORRESGTORRESUGTCOLSRTGTSTRESCGTSTRESNGTSTRESUGTSTATGTREASNDGTMETHODGTDTC
18325064AmesGT11_1RPPRevertant Colony Numbers Per Plate26NOT APPLICABLE
2626

NOT APPLICABLE

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INSTRUMENT COUNTED

2015-08-03
28325064AmesGT21_2RPPRevertant Colony Numbers Per Plate35NOT APPLICABLE
3535NOT APPLICABLE

INSTRUMENT COUNTED2015-08-03
38325064AmesGT31_3RPPRevertant Colony Numbers Per Plate39NOT APPLICABLE
3939NOT APPLICABLE

INSTRUMENT COUNTED2015-08-03
48325064AmesGT41_4RPPRevertant Colony Numbers Per Plate35NOT APPLICABLE
3535NOT APPLICABLE

INSTRUMENT COUNTED

2015-08-03
58325064AmesGT51_5RPPRevertant Colony Numbers Per Plate30NOT APPLICABLE
3030NOT APPLICABLE

INSTRUMENT COUNTED2015-08-03
68325064AmesGT6ARPPRevertant Colony Numbers Per Plate33.0NOT APPLICABLEMEAN33.033.0NOT APPLICABLE


2015-08-03
78325064AmesGT7ARPPRevertant Colony Numbers Per Plate5.0NOT APPLICABLESTANDARD DEVIATION5.05.0NOT APPLICABLE


2015-08-03
88325064AmesGT16_1RPPRevertant Colony Numbers Per Plate8NOT APPLICABLE
88NOT APPLICABLE

MANUALLY COUNTED2015-08-03
98325064AmesGT26_1CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
108325064AmesGT36_2RPPRevertant Colony Numbers Per Plate10NOT APPLICABLE
1010NOT APPLICABLE

MANUALLY COUNTED2015-08-03
118325064AmesGT46_2CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
128325064AmesGT56_3RPPRevertant Colony Numbers Per Plate12NOT APPLICABLE
1212NOT APPLICABLE

MANUALLY COUNTED2015-08-03
138325064AmesGT66_3CYTOTOXCytotoxicityVery thin background bacterial lawn

V




2015-08-03
148325064AmesGT7FRPPMEANMean Rev Colony Num Per Plate

10.0

NOT APPLICABLEMEAN

10.0

10.0

NOT APPLICABLE


2015-08-03
158325064AmesGT8FRPPSTDDVStd Dev Rev Colony Num Per Plate2.0NOT APPLICABLESTANDARD DEVIATION2.02.0NOT APPLICABLE


2015-08-03
168325064AmesGT9FRPPFLDICFold Increase Rev Colony Num Per Plate0.3NOT APPLICABLEFOLD INCREASE0.30.3NOT APPLICABLE


2015-08-03
178325064AmesGT17_1CYTOTOXCytotoxicity

Toxic No Revertant Colonies



T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
188325064AmesGT27_2CYTOTOXCytotoxicityToxic No Revertant Colonies

T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
198325064AmesGT37_3CYTOTOXCytotoxicityToxic No Revertant Colonies

T

NOT DONETOO MUCH CYTOTOXICITY
2015-08-03
208325064AmesGT118_1RPPRevertant Colony Numbers Per Plate

812

NOT APPLICABLE


812

812

NOT APPLICABLE

INSTRUMENT COUNTED

2015-08-03
218325064AmesGT218_2RPPRevertant Colony Numbers Per Plate

912

NOT APPLICABLE


912

912

NOT APPLICABLE

INSTRUMENT COUNTED2015-08-03
228325064AmesGT318_3RPPRevertant Colony Numbers Per Plate

839

NOT APPLICABLE


839

839

NOT APPLICABLE

INSTRUMENT COUNTED2015-08-03
238325064AmesGT4RRPPMEANMean Rev Colony Num Per Plate854.3NOT APPLICABLEMEAN854.3854.3NOT APPLICABLE


2015-08-03
248325064AmesGT5RRPPSTDDVStd Dev Rev Colony Num Per Plate51.7NOT APPLICABLESTANDARD DEVIATION51.751.7NOT APPLICABLE


2015-08-03
258325064AmesGT6RRPPFLDICFold Increase Rev Colony Num Per Plate6.4NOT APPLICABLEFOLD INCREASE6.46.4NOT APPLICABLE


2015-08-03