FDA.reportPublic FDA data

PROTEUS POLY ANTISERUM

Primary DI
00695684013035
Brand
PROTEUS POLY ANTISERUM
Company
GERMAINE LABORATORIES, INC
Model
1303
Device description
Proteus Poly Antiserum is a positive control intended for use in febrile tests.
Published
2016-04-27
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
GSYAntisera, Fluorescent, All Globulins, Proteus Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GSYAntisera, Fluorescent, All Globulins, Proteus Spp.Microbiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00695684013035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684013035006956840130356956840130350695684013035

GMDN Terms#

Term, Definition table
TermDefinition
Multiple febrile infection-associated bacteria antigen IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from one or multiple bacteria associated with febrile infection in a clinical specimen. Bacteria detected may include Brucella, Salmonella and/or Rickettsia.

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
05056080501598Proteus OX2 Agglutinating SerumREMEL EUROPE LIMITEDGSY2021-07-21
05056080501604Proteus OX19 Agglutinating SerumREMEL EUROPE LIMITEDGSY2021-07-21
05056080501611Proteus OXK Agglutinating SerumREMEL EUROPE LIMITEDGSY2021-07-21
00695684012007PROTEUS OXK ANTIGENGERMAINE LABORATORIES, INCGSY2016-04-27
00695684012014PROTEUS OX2 ANTIGENGERMAINE LABORATORIES, INCGSY2016-04-27
00695684012021PROTEUS OX19 ANTIGENGERMAINE LABORATORIES, INCGSY2016-04-27