STANBIO LABORATORY, L.P.

Address:1261 NORTH MAIN ST.,Boerne,TX,78006,US

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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, Streptococcus Spp. (GTY) (2) System, Hemoglobin, Automated (GKR) (2) Visual, Pregnancy Hcg, Prescription Use (JHI) (2) Reagent, Occult Blood (KHE) (1)

Premarket Exempt

No Yes

Clear

QuPID® hCG - 00657498122013 Catalog Number : 1220-025

Device Description : For the qualitative determination of human chorionic gonadotropin (hCG) in urine For the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

Device Class :

Duns Number: 045361136

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 25

QuPID® hCG - 00657498122020 Catalog Number : 1220-050

Device Class :

Duns Number: 045361136

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 50

Hema-Screen Lab Pack - 00657498129012 Catalog Number : 1290-100

Device Description : Hema-Screen is a guaiac slide test for the qualitative detection of fecal occult blood.

Device Class :

Duns Number: 045361136

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 100

HemoPoint H2 - 00657498300039 Catalog Number : G3000-CONTCUV

Device Description : The HemoPoint® H2 system is intended for the quantitative determination of hemog The HemoPoint® H2 system is intended for the quantitative determination of hemoglobin (Hgb) in whole blood of adults, infants, and children in a professional point-of-care setting. It consists of a dedicated photometer and individual, single-use microcuvettes filled with reagents.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 1

HemoPoint® H2 n•x•t Microcuvettes - 00657498301654 Catalog Number : 3016-050

Device Description : For the quantitative determination of hemoglobin in capillary, venous or arteria For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood.

Device Class :

Duns Number: 045361136

Premarket Exempt : No

Product Code : GKR

Prescription Use : Yes

Device Count : 50

QuSTICK™ Strep A - 00657498600016 Catalog Number : 6000-025

Device Description : A rapid test for the qualitative detection of Strep A antigen in throat swab specimens.

Device Class :

Duns Number: 045361136

Premarket Exempt : No

Product Code : GTY

Prescription Use : Yes

Device Count : 25

QuSTICK™ Strep A - 00657498600023 Catalog Number : 6000-050

Device Description : A rapid test for the qualitative detection of Strep A antigen in throat swab specimens.

Device Class :

Duns Number: 045361136

Premarket Exempt : No

Product Code : GTY

Prescription Use : Yes

Device Count : 50

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