GERMAINE LABORATORIES, INC

Address:11030 Wye Drive,SAN ANTONIO,TX,78217,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Antisera, Fluorescent, All Globulins, Proteus Spp. (GSY) (4) Antigens, All Groups, Salmonella Spp. (GRL) (3) Antigens (Febrile), Agglutination, Brucella Spp. (GSO) (2) Antisera, Fluorescent, Brucella Spp. (GSM) (1)

Premarket Exempt

No Yes

Clear

BRUCELLA ABORTUS ANTIGEN - 00695684010003 Catalog Number :

Device Description : Brucella Abortus Antigens are intended for the detection of bacterial agglutinin Brucella Abortus Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection.

Device Class : 2

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GSO

Prescription Use : Yes

Device Count : 1

BRUCELLA MELITENSIS ANTIGEN - 00695684010027 Catalog Number :

Device Description : Brucella Melitensis Antigens are intended for the detection of bacterial aggluti Brucella Melitensis Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection.

Device Class : 2

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GSO

Prescription Use : Yes

Device Count : 1

BRUCELLA ABORTUS ANTISERUM - 00695684011000 Catalog Number :

Device Description : Brucella Abortus Antiserum is intended for use as control material for Brucella antigens.

Device Class : 2

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GSM

Prescription Use : Yes

Device Count : 1

PROTEUS OXK ANTIGEN - 00695684012007 Catalog Number :

Device Description : Proteus OXK Antigens are intended for the detection of bacterial agglutinins ass Proteus OXK Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection.

Device Class : 1

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GSY

Prescription Use : Yes

Device Count : 1

PROTEUS OX2 ANTIGEN - 00695684012014 Catalog Number :

Device Description : Proteus OX2 Antigens are intended for the detection of bacterial agglutinins ass Proteus OX2 Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection.

Device Class : 1

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GSY

Prescription Use : Yes

Device Count : 1

PROTEUS OX19 ANTIGEN - 00695684012021 Catalog Number :

Device Description : Proteus OX19 Antigens are intended for the detection of bacterial agglutinins as Proteus OX19 Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection.

Device Class : 1

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GSY

Prescription Use : Yes

Device Count : 1

PROTEUS POLY ANTISERUM - 00695684013035 Catalog Number :

Device Description : Proteus Poly Antiserum is a positive control intended for use in febrile tests.

Device Class : 1

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GSY

Prescription Use : Yes

Device Count : 1

SALMONELLA H a ANTIGEN - 00695684014001 Catalog Number :

Device Description : Salmonella H a Antigens are intended for the detection of bacterial agglutinins Salmonella H a Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection.

Device Class : 2

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GRL

Prescription Use : Yes

Device Count : 1

SALMONELLA H b ANTIGEN - 00695684014018 Catalog Number :

Device Description : Salmonella H b Antigens are intended for the detection of bacterial agglutinins Salmonella H b Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection.

Device Class : 2

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GRL

Prescription Use : Yes

Device Count : 1

SALMONELLA H c ANTIGEN - 00695684014025 Catalog Number :

Device Description : Salmonella H c Antigens are intended for the detection of bacterial agglutinins Salmonella H c Antigens are intended for the detection of bacterial agglutinins associated with a bacterial infection.

Device Class : 2

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GRL

Prescription Use : Yes

Device Count : 1

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