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

Antigens, All Groups, Salmonella Spp. (GRL) (5) Antiserum, Positive And Negative Febrile Antigen Control Serum (GSN) (4) Antiserum, Francisella Tularensis (GSK) (1)

Premarket Exempt

No Yes

Clear

SALMONELLA H d ANTIGEN - 00695684014032 Catalog Number :

Device Description : Febrile Antigens are intended for the detection of bacterial agglutinins associa Febrile 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 O GROUP A ANTIGEN - 00695684015008 Catalog Number :

Device Description : Salmonella O Group A Antigens are intended for the detection of bacterial agglut Salmonella O Group 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 O GROUP B ANTIGEN - 00695684015015 Catalog Number :

Device Description : Salmonella O Group B Antigens are intended for the detection of bacterial agglut Salmonella O Group 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 O GROUP C ANTIGEN - 00695684015022 Catalog Number :

Device Description : Salmonella O Group C Antigens are intended for the detection of bacterial agglut Salmonella O Group 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

SALMONELLA O GROUP D ANTIGEN - 00695684015039 Catalog Number :

Device Description : Salmonella O Group D Antigens are intended for the detection of bacterial agglut Salmonella O Group D 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

FEBRILE POSITIVE CONTROL - 00695684016005 Catalog Number :

Device Description : Febrile Positive Control is intended for use as a positive control for Febrile A Febrile Positive Control is intended for use as a positive control for Febrile Antigen tests.

Device Class : 2

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GSN

Prescription Use : Yes

Device Count : 1

FEBRILE NEGATIVE CONTROL - 00695684016012 Catalog Number :

Device Description : Febrile Negative Control is intended for use as a negative control for Febrile A Febrile Negative Control is intended for use as a negative control for Febrile Antigen tests.

Device Class : 2

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GSN

Prescription Use : Yes

Device Count : 1

SALMONELLA H POLY POSITIVE CONTROL - 00695684016067 Catalog Number :

Device Description : Febrile Controls are intended for use as positive & negative controls for these tests.

Device Class : 2

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GSN

Prescription Use : Yes

Device Count : 1

SALMONELLA O POLY POSITIVE CONTROL - 00695684016111 Catalog Number :

Device Description : Salmonella O Poly Positive controls are intended for use as positive controls fo Salmonella O Poly Positive controls are intended for use as positive controls for salmonella somatic antigens.

Device Class : 2

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GSN

Prescription Use : Yes

Device Count : 1

FRANCISELLA TULARENSIS ANTISERUM - 00695684017026 Catalog Number :

Device Description : Francisella Tularensis Antiserum is intended for use as a postive control for Fr Francisella Tularensis Antiserum is intended for use as a postive control for Francisella Tularensis Antigens.

Device Class : 2

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GSK

Prescription Use : Yes

Device Count : 1

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