GERMAINE LABORATORIES, INC

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

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Device Description : The AimStrip® Hemoglobin Testing System is for the quantitative determination o The AimStrip® Hemoglobin Testing System is for the quantitative determination of hemoglobin in non-anticoagulated capillary whole blood or anticoagulated venous whole blood in EDTA or sodium heparin.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 50

Device Description : For testing hemoglobin in whole blood

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KHG, GIG

Prescription Use : Yes

Device Count : 200

Device Description : For testing hemoglobin in whole blood

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KHG

Prescription Use : Yes

Device Count : 50

Device Description : Urine dipstick test. For the rapid qualitative determination of human Chorionic Urine dipstick test. For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 30

Device Description : Dipstick test. For the rapid qualitative determination of human Chorionic Gonad Dipstick test. For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in serum or urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 30

Device Description : Urine Midstream, Rapid qualitative test to detect the presence of hCG in urine. Urine Midstream, Rapid qualitative test to detect the presence of hCG in urine. Designed for self testing (home). Results within 3 minutes.

Device Class : 2

Duns Number: 176458115

Premarket Exempt : No

Product Code : DHA

Prescription Use : No

Device Count : 1

Device Description : Urine Midstream, Rapid qualitative test to detect the presence of hCG in urine. Urine Midstream, Rapid qualitative test to detect the presence of hCG in urine. Designed for self testing (home). Results within 3 minutes.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DHA

Prescription Use : No

Device Count : 2

Device Description : Urine Midstream, Rapid qualitative test to detect the presence of hCG in urine. Urine Midstream, Rapid qualitative test to detect the presence of hCG in urine. Designed for self testing (home). Results within 3 minutes.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DHA

Prescription Use : No

Device Count : 40

Device Description : Urine Midstream, Rapid qualitative test to detect the presence of hCG in urine. Urine Midstream, Rapid qualitative test to detect the presence of hCG in urine. Designed for self testing (home). Results within 3 minutes.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : DHA

Prescription Use : No

Device Count : 2

Device Description : Urine cassette test. For the rapid qualitative determination of human Chorionic Urine cassette test. For the rapid qualitative determination of human Chorionic Gonadotropin (hCG) in urine.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 25