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

Acid, Uric, Uricase (Colorimetric) (KNK) (1) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (1) Enzymatic Method, Creatinine (JFY) (1) Hexokinase, Glucose (CFR) (1) Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl (LBS) (1) Phosphomolybdate (Colorimetric), Inorganic Phosphorus (CEO) (1) Photometric Method, Iron (Non-Heme) (JIY) (1) System, Test, Low Density, Lipoprotein (MRR) (1) U.V. Method, Cpk Isoenzymes (JHW) (1) Urease And Glutamic Dehydrogenase, Urea Nitrogen (CDQ) (1)

Premarket Exempt

No Yes

Clear

Sirrus® Total Iron LiquiColor® - 00657498001530 Catalog Number : S0370-600

Device Description : For the Quantitative Colorimetric Determination of Iron in Serum.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : JIY

Prescription Use : Yes

Device Count : 1

CK-MB Liqui-UV® - 00657498001547 Catalog Number : 2980-430

Device Description : For the Quantitative Determination of Creatine Kinase-MB in Serum for Manual and For the Quantitative Determination of Creatine Kinase-MB in Serum for Manual and/or Automated Procedures.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : JHW

Prescription Use : Yes

Device Count : 1

Sirrus® Creatinine LiquiColor® - 00657498001554 Catalog Number : S0430-600

Device Description : For the Quantitative Determination of Creatinine in Serum and Urine.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : JFY

Prescription Use : Yes

Device Count : 1

Sirrus® Direct HDL Cholesterol LiquiColor® - 00657498001561 Catalog Number : S0590-540

Device Description : For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol in Human Serum.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : LBS

Prescription Use : Yes

Device Count : 1

Sirrus® Direct LDL Cholesterol LiquiColor® - 00657498001578 Catalog Number : S0710-540

Device Description : For the qualitative determination of LDL Cholesterol in serum and plasma.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : MRR

Prescription Use : Yes

Device Count : 1

Sirrus® Phosphorus Liqui-UV® - 00657498001585 Catalog Number : S0830-750

Device Description : For the Quantitative UV Determination of Inorganic Phosphorus in Serum, Plasma and Urine.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : CEO

Prescription Use : Yes

Device Count : 1

Sirrus® Total Cholesterol LiquiColor® - 00657498001592 Catalog Number : S1010-750

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

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : CHH

Prescription Use : Yes

Device Count : 1

Sirrus® Uric Acid LiquiColor® - 00657498001608 Catalog Number : S1045-750

Device Description : For the Quantitative Colorimetric Determination of Uric Acid in Serum, Plasma or Urine.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : KNK

Prescription Use : Yes

Device Count : 1

Sirrus® Glucose Liqui-UV® - 00657498001615 Catalog Number : S1060-600

Device Description : For the Quantitative Determination of Glucose in Serum, Plasma, CSF or Urine.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : CFR

Prescription Use : Yes

Device Count : 1

Sirrus® Urea Nitrigen (BUN) Liqui-UV® - 00657498001622 Catalog Number : S2020-600

Device Description : For the Kinetic Quantitative Determination of Urea Nitrogen (BUN) in Serum and Plasma.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : CDQ

Prescription Use : Yes

Device Count : 1

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