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

Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl (LBS) (3) Enzymatic Esterase--Oxidase, Cholesterol (CHH) (2) Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1) System, Test, Low Density, Lipoprotein (MRR) (1) Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes (CGS) (1) Ldl & Vldl Precipitation, Hdl (LBR) (1)

Premarket Exempt

No Yes

Clear

Cholesterol LiquiColor® - 00657498000649 Catalog Number : 1010-430

Device Description : For the Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Chole For the Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Cholesterol in Serum or Plasma.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : CHH

Prescription Use : Yes

Device Count : 1

Cholesterol LiquiColor® - 00657498000656 Catalog Number : 1010-225

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : CHH

Prescription Use : Yes

Device Count : 1

HDL Cholesterol Precipitating Reagent - 00657498000663 Catalog Number : 0599-020

Device Description : For Use in the Determination of High Density Lipoprotein (HDL) Cholesterol in Se For Use in the Determination of High Density Lipoprotein (HDL) Cholesterol in Serum or Plasma.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : LBR

Prescription Use : Yes

Device Count : 1

Direct HDL Cholesterol LiquiColor® - 00657498000670 Catalog Number : 0590-040

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

Direct HDL Cholesterol LiquiColor® - 00657498000687 Catalog Number : 0590-080

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

Direct HDL Cholesterol LiquiColor® - 00657498000694 Catalog Number : 0590-500

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

Direct LDL Cholesterol LiquiColor® - 00657498000700 Catalog Number : 0710-080

Device Description : For the Quantitative Determination of Low Density Lipoprotein (LDL) Cholesterol For the Quantitative Determination of Low Density Lipoprotein (LDL) Cholesterol in Human Serum or Plasma.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : MRR

Prescription Use : Yes

Device Count : 1

Direct (HDL/LDL) Cholesterol Calibrator - 00657498000717 Catalog Number : 0595-003

Device Description : For the Calibration of Stanbio HDL Cholesterol and LDL Cholesterol LiquiColor® R For the Calibration of Stanbio HDL Cholesterol and LDL Cholesterol LiquiColor® Reagent Kits.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

CK Liqui-UV® - 00657498000724 Catalog Number : 2910-430

Device Description : For the Kinetic Quantitative Determination of Creatine Kinase in Serum.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : CGS

Prescription Use : Yes

Device Count : 1

STAT-Site M B-HB Code Key - 00657498000731 Catalog Number : 401020

Device Description : The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to acc The STAT-Site® Mß-HB Meter is a dedicated reflectance photometer designed to accept only STAT-Site® Mß-HB CODE Keys and STAT-Site® Mß-HB Test Strips. This test system is intended or the quantitative determination of ß-hydroxybutyrate in serum or plasma.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : No

Product Code : JIN

Prescription Use : Yes

Device Count : 1

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