STANBIO LABORATORY, L.P.

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

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Device Description : For Use as Controls in Quantitative Procedures for Acetaminophen, Salicylate, an For Use as Controls in Quantitative Procedures for Acetaminophen, Salicylate, and ß-Hydroxybutyrate.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : DIF

Prescription Use : Yes

Device Count : 1

Device Description : For Use as Linearity Standards in Quantitative Procedures for Acetaminophen, Sal For Use as Linearity Standards in Quantitative Procedures for Acetaminophen, Salicylate, Theophylline, and ß-Hydroxybutyrate.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : DKB

Prescription Use : Yes

Device Count : 1

Device Description : For the quantitative colorimetric determination of Direct Bilirubin in Serum and Plasma.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : JFM

Prescription Use : Yes

Device Count : 1

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 : CIG

Prescription Use : Yes

Device Count : 1

Device Description : The Stanbio Total Bilirubin LiquiColor® test system is a device intended to meas The Stanbio Total Bilirubin LiquiColor® test system is a device intended to measure the levels of bilirubin (total) in serum and plasma. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : JFM

Prescription Use : Yes

Device Count : 1

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

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : CIG

Prescription Use : Yes

Device Count : 1

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

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : CIG

Prescription Use : Yes

Device Count : 1

Device Description : For the Quantitative Colorimetric determination of Total Calcium in serum.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : CJY

Prescription Use : Yes

Device Count : 1

Device Description : For the Quantitative Colorimetric determination of Total Calcium in serum, plasm For the Quantitative Colorimetric determination of Total Calcium in serum, plasma or urine.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : CIC

Prescription Use : Yes

Device Count : 1

- Catalog Number : 0210-250

Device Description : Quantitative Colorimetric Determination of Chloride in Serum, Plasma, Urine and CSF.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : CHJ

Prescription Use : Yes

Device Count : 1