GERMAINE LABORATORIES, INC

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

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Device Description : Patient collection kits for IFOB kit

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 15

Device Description : Immunological fecal occult blood rapid assay for the qualitative detection of fe Immunological fecal occult blood rapid assay for the qualitative detection of fecal occult blood in human stool samples.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 30

Device Description : Immunological fecal occult blood rapid assay for the qualitative detection of fe Immunological fecal occult blood rapid assay for the qualitative detection of fecal occult blood in human stool samples.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 30

Device Description : Immunological fecal occult blood rapid assay for the qualitative detection of fe Immunological fecal occult blood rapid assay for the qualitative detection of fecal occult blood in human stool samples. Full Compliance.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 30

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 30

Device Description : Fecal occult blood rapid assay for the qualitative detection of occult blood in Fecal occult blood rapid assay for the qualitative detection of occult blood in human stool samples.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 100

Device Description : Developer solution for use with Compliance Gold FOB tests.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 8

Device Description : IFOB Controls

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 2

Device Description : Triple slide patient take home version of a rapid test for the qualitative detec Triple slide patient take home version of a rapid test for the qualitative detection of occult blood in stool specimens.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 50

Device Description : Triple slide patient take home version of a rapid test for the qualitative detec Triple slide patient take home version of a rapid test for the qualitative detection of occult blood in stool specimens. Full Compliance features include Pre-Paid postage return envelops, compliance monitoring reminders, return labels.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 50