GERMAINE LABORATORIES, INC

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

Want to know more about this Organization? Request more information now!

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

Radioimmunoassay, Luteinizing Hormone (CEP) (4) System, Hemoglobin, Automated (GKR) (2) Control, Hemoglobin (GGM) (1) Radioimmunoassay, Thyroid-Stimulating Hormone (JLW) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1) System, Test, Infectious Mononucleosis (KTN) (1)

Premarket Exempt

No Yes

Clear

AIMSTEP OVULATION - 00695684750305 Catalog Number :

Device Description : A qualitative test to detect the LH surge in urine to aid in the prediction of ovulation.

Device Class :

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : Yes

Device Count : 30

Mosie Baby Ovulation Test - 00695684754075 Catalog Number :

Device Description : Urine Midstream. Rapid qualitative test to detect the LH surge in urine. Designe Urine Midstream. Rapid qualitative test to detect the LH surge in urine. Designed to aid in the prediction of ovulation, for self testing (home).

Device Class :

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : No

Device Count : 7

ACCUHOME OVULATION - 00695684755010 Catalog Number :

Device Class : 1

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : No

Device Count : 1

ACCUHOME OVULATION - 00695684755409 Catalog Number :

Device Class :

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : CEP

Prescription Use : No

Device Count : 40

AIMSTEP THYROID SCREEN - 00695684762209 Catalog Number :

Device Description : Cassette test for TSH in fingerstick whole blood

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : JLW

Prescription Use : Yes

Device Count : 20

AIMSTEP MONO - 00695684770259 Catalog Number :

Device Description : A rapid cassette test for the qualitative detection of Infectious Mononucleosis A rapid cassette test for the qualitative detection of Infectious Mononucleosis (IM) heterophile antibodies in serum, plasma, or whole blood.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : KTN

Prescription Use : Yes

Device Count : 25

AIMSTRIP HEMOGLOBIN METER - 00695684781019 Catalog Number :

Device Description : For the quantitative determination of hemoglobin in non-anticoagulated capillary For the quantitative determination of hemoglobin in non-anticoagulated capillary whole blood or anticoagulated venous whole blood in EDTA or sodium heparin. The testing system is designed for point-of-care use in primary care settings.

Device Class : 2

Duns Number: 176458115

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 1

AIMSTRIP HEMOGLOBIN OPTICAL VERIFIERS - 00695684781026 Catalog Number :

Device Description : AimStrip® Hb Optical Verifiers are made out of plastic and work with the AimStri AimStrip® Hb Optical Verifiers are made out of plastic and work with the AimStrip® HB Hemoglobin (Hb) Meter.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 2

AIMSTRIP HEMOGLOBIN CONTROL SET - 00695684781033 Catalog Number :

Device Description : Intended to validate hemoglobin testing using the AimStrip® HB Hemoglobin Testing System.

Device Class :

Duns Number: 176458115

Premarket Exempt : No

Product Code : GGM

Prescription Use : Yes

Device Count : 3

AIMSTRIP Hb ADAPTOR - 00695684781118 Catalog Number :

Device Description : 1 AC Adaptor (for meter)

Device Class : 2

Duns Number: 176458115

Premarket Exempt : Yes

Product Code : GKR

Prescription Use : Yes

Device Count : 1

Previous 1 … 11 12 13 14 15 Next