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

Catalytic Methods, Amylase (JFJ) (1) Kinetic Method, Gamma-Glutamyl Transpeptidase (JQB) (1) Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides (CDT) (1) Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes (CGS) (1) Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase (CFJ) (1) Nadh Oxidation/Nad Reduction, Alt/Sgpt (CKA) (1) Nadh Oxidation/Nad Reduction, Ast/Sgot (CIT) (1) Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (CJE) (1)

Premarket Exempt

Yes No

Clear

Sirrus® Triglyceride LiquiColor® - 00657498001639 Catalog Number : S2200-750

Device Description : For the Quantitative Colorimetric Determination of Triglycerides in Serum and Plasma.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : CDT

Prescription Use : Yes

Device Count : 1

Sirrus® Alkaline Phosphatase LiquiColor® - 00657498001646 Catalog Number : S2900-600

Device Description : For the Kinetic Quantitative Determination of Alkaline Phosphatase in Serum or Plasma.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : CJE

Prescription Use : Yes

Device Count : 1

Sirrus® CK Liqui-UV® - 00657498001653 Catalog Number : S2910-600

Device Description : Creatine test system is a device intended to measure creatine (a substance synth Creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : CGS

Prescription Use : Yes

Device Count : 1

Sirrus® AST/SGOT Liqui-UV® - 00657498001660 Catalog Number : S2920-600

Device Description : For the Kinetic Quantitative Determination of AST/GOT in Serum or Plasma.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : CIT

Prescription Use : Yes

Device Count : 1

Sirrus® ALT/SGPT Liqui-UV® - 00657498001677 Catalog Number : S2930-600

Device Description : For the Kinetic Quantitative Determination of ALT/GPT in Serum and Plasma.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : CKA

Prescription Use : Yes

Device Count : 1

Sirrus® LDH Liqui-UV® - 00657498001684 Catalog Number : S2940-600

Device Description : For the Quantitative Determination of Lactate Dehydrogenase in Serum.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : CFJ

Prescription Use : Yes

Device Count : 1

Sirrus® Gamma-GT LiquiColor® - 00657498001691 Catalog Number : S2960-600

Device Description : A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : JQB

Prescription Use : Yes

Device Count : 1

Sirrus® Alpha-Amylase LiquiColor® - 00657498001707 Catalog Number : S2970-750

Device Description : For the Quantitative Determination of Amylase in Serum, Heparin Plasma and Urine.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : JFJ

Prescription Use : Yes

Device Count : 1

Sirrus® Cuvette Detergent 1 - 00657498001714 Catalog Number : 2208-640

Device Description : For use as a wash for cuvettes on the Sirrus® Chemistry Analyzer.

Device Class :

Duns Number: 045361136

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Sirrus® Cuvette Detergent 2 - 00657498001721 Catalog Number : 2209-620

Device Description : For use as a wash for cuvettes on the Sirrus® Chemistry Analyzer.

Device Class :

Duns Number: 045361136

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

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