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

Visual, Pregnancy Hcg, Prescription Use (JHI) (2) Enzymatic Method, Bilirubin (JFM) (2) Azo Dye, Calcium (CJY) (1) Biuret (Colorimetric), Total Protein (CEK) (1) Albumin, Antigen, Antiserum, Control (DCF) (1) Enzymatic, Carbon-Dioxide (KHS) (1) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1) Assay, Glycosylated Hemoglobin (LCP) (1)

Premarket Exempt

No Yes

Clear

TRUE® 20 PLUS hCG - 00657498001370 Catalog Number : 1440-050

Device Description : A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG) in Serum or Urine.

Device Class :

Duns Number: 045361136

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 50

TRUE® 20 PLUS hCG - 00657498001400 Catalog Number : 1440-025

Device Class :

Duns Number: 045361136

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 25

Bi-Level Hgb Controls - 00657498001431 Catalog Number : 3065-201

Device Description : A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin t A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin testing system.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Sirrus® Calcium LiquiColor® - 00657498001462 Catalog Number : S0155-750

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

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : CJY

Prescription Use : Yes

Device Count : 1

Sirrus® Bicarbonate (CO2) LiquiColor® - 00657498001479 Catalog Number : S0190-750

Device Description : For the Quantitative Determination of Bicarbonate (CO2) in Serum and Plasma.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : KHS

Prescription Use : Yes

Device Count : 1

Sirrus® Total Bilirubin LiquiColor® - 00657498001486 Catalog Number : S0230-600

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

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : JFM

Prescription Use : Yes

Device Count : 1

Sirrus® Direct Bilirubin LiquiColor® - 00657498001493 Catalog Number : S0235-600

Device Description : For the Quantitative Colorimetric Determination of Direct Bilirubin in Serum or Plasma.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : JFM

Prescription Use : Yes

Device Count : 1

Sirrus® Total Protein LiquiColor® - 00657498001509 Catalog Number : S0250-750

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

Device Class : 2

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : CEK

Prescription Use : Yes

Device Count : 1

Sirrus® Albumin LiquiColor® - 00657498001516 Catalog Number : S0285-750

Device Description : For the quantitative determination of albumin in serum and plasma. Albumin meas For the quantitative determination of albumin in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : DCF

Prescription Use : Yes

Device Count : 1

Sirrus® Direct Gylcohemoglobin (HbA1c) - 00657498001523 Catalog Number : S0360-200

Device Description : For the Quantitative Determination of Glycohemoglobin (HbA1c) in human blood.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

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