FDA.reportPublic FDA data

SALMONELLA H d ANTIGEN

Primary DI
00695684014032
Brand
SALMONELLA H d ANTIGEN
Company
GERMAINE LABORATORIES, INC
Model
1403
Device description
Febrile Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection.
Published
2016-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GRLAntigens, All Groups, Salmonella Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GRLAntigens, All Groups, Salmonella Spp.Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00695684014032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684014032006956840140326956840140320695684014032

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176458115
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00695684744250AimStep Flu A&B Test Kit744252026-05-11
00695684773014AimStrip Tandem Lipid Profile and glucose measuring systemILM-0001A2020-03-13
00695684775506AimStrip Tandem blood glucose test stripsILM-0001A2020-03-13
00695684773106AimStrip Tandem Total Cholesterol Test StripsILM-0001A2020-03-13
00695684773120AimStrip Tandem Total Cholesterol Control SolutionILM-0001A2020-03-13
00695684774103AimStrip Tandem Total Triglycerides Test StripsILM-0001A2020-03-13
00695684774127AimStrip Tandem Total Triglycerides Control SolutionILM-0001A2020-03-13
00695684775124AimStrip Tandem Glucose control solutionILM-0001A2020-03-13
00695684423384AimScreen Fentanyl423382024-04-01
10695684423381AimScreen Fentanyl423382024-04-01
00695684893019Pregcolor Plus893012023-08-09
00695684971014Pregcolor Premium 97101PCP2023-08-09
00695684957018Mosie Baby Pregnancy Test957012019-10-21
00695684885304AIMSTRIP PREGNANCY885302016-04-11
00695684888305AIMSTRIP COMBO PREGNANCY888302016-04-27
00695684891015AccuHome Pregnancy Test891012016-04-11
00695684891022AccuHome Pregnancy Test891022016-04-11
00695684891404AccuHome Pregnancy Test891402016-04-11
00695684970253AIMSTEP PREGNANCY970252016-04-11
00695684970307AIMSTEP PREGNANCY970302016-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05713106821510S. Agona reference strainSsi Diagnostica A/SGRL2016-09-15
05713106821527S. Braenderup reference strainSsi Diagnostica A/SGRL2016-09-15
05713106821534S. Derby reference strainSsi Diagnostica A/SGRL2016-09-15
05713106821541S. Enteritidis reference strainSsi Diagnostica A/SGRL2016-09-15
05713106821558S. Hadar reference strainSsi Diagnostica A/SGRL2016-09-15
05713106821572S. Heidelberg reference strainSsi Diagnostica A/SGRL2016-09-15
05713106821589S. Infantis reference strainSsi Diagnostica A/SGRL2016-09-15
05713106821602S. Montevideo reference strainSsi Diagnostica A/SGRL2016-09-15
05713106821619S. Newport reference strainSsi Diagnostica A/SGRL2016-09-15
05713106821626S. Paratyphi A reference strainSsi Diagnostica A/SGRL2016-09-15
05713106821633S. Saintpaul reference strainSsi Diagnostica A/SGRL2016-09-15
05713106821640S. Senftenberg reference strainSsi Diagnostica A/SGRL2016-09-15
05713106821657S. Stanley reference strainSsi Diagnostica A/SGRL2016-09-15
05713106821664S. Typhimurium reference strainSsi Diagnostica A/SGRL2016-09-15
05713106821671S. Virchow reference strainSsi Diagnostica A/SGRL2016-09-15
00382902117506BD Difco™ QC Antigen Salmonella O Group E1BECTON, DICKINSON AND COMPANYGRL2016-07-07
00382902117513BD Difco™ QC Antigen Salmonella O Group E2BECTON, DICKINSON AND COMPANYGRL2016-07-07
00382902117537BD Difco™ QC Antigen Salmonella O Group FBECTON, DICKINSON AND COMPANYGRL2016-07-07
00382902117544BD Difco™ QC Antigen Salmonella O Group G1BECTON, DICKINSON AND COMPANYGRL2016-07-07
00382902117575BD Difco™ QC Antigen Salmonella O Group IBECTON, DICKINSON AND COMPANYGRL2016-07-07
00382902213017BD Difco™ QC Antigen Salmonella O Group ABECTON, DICKINSON AND COMPANYGRL2016-04-28
00382902213116BD Difco™ QC Antigen Salmonella O Group BBECTON, DICKINSON AND COMPANYGRL2016-04-28
00382902213215BD Difco™ QC Antigen Salmonella O Group C1BECTON, DICKINSON AND COMPANYGRL2016-04-28
00382902213314BD Difco™ QC Antigen Salmonella O Group C2BECTON, DICKINSON AND COMPANYGRL2016-04-28
00382902213413BD Difco™ QC Antigen Salmonella O Group DBECTON, DICKINSON AND COMPANYGRL2016-04-28
00382902213710BD Difco™ QC Antigen Salmonella O Group E4BECTON, DICKINSON AND COMPANYGRL2016-04-28
00382902214014BD Difco™ QC Antigen Salmonella O Group HBECTON, DICKINSON AND COMPANYGRL2016-04-28
00382902214212BD Difco™ QC Antigen Salmonella ViBECTON, DICKINSON AND COMPANYGRL2016-04-28
00695684015039SALMONELLA O GROUP D ANTIGENGERMAINE LABORATORIES, INCGRL2016-04-27
00695684014001SALMONELLA H a ANTIGENGERMAINE LABORATORIES, INCGRL2016-04-21