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

Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission (PTF) (3) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (3) Automated Urinalysis System (KQO) (1) Electrode, Ion Specific, Potassium (CEM) (1) Electrode, Ion Specific, Sodium (JGS) (1) Electrode, Ion-Specific, Chloride (CGZ) (1)

Premarket Exempt

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ISE Sodium Electrode - 00657498001882 Catalog Number : 20270474

Device Description : Ion-Selective Electrode for the measurement of sodium in serum.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : JGS

Prescription Use : Yes

Device Count : 1

ISE Chloride Electrode - 00657498001899 Catalog Number : 20270475

Device Description : Ion-Selective Electrode for the measurement of chloride in serum.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : CGZ

Prescription Use : Yes

Device Count : 1

ISE Potassium Electrode - 00657498001905 Catalog Number : 20270476

Device Description : Ion-Selective Electrode for the measurement of potassium in serum.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : CEM

Prescription Use : Yes

Device Count : 1

Procalcitonin LiquiColor - 00657498001950 Catalog Number : 2300-060

Device Description : Stanbio Procalcitonin (PCT) LiquiColor® is intended for the quantitative determi Stanbio Procalcitonin (PCT) LiquiColor® is intended for the quantitative determination of PCT in human serum samples, EDTA or lithium heparin plasma samples by latex enhanced immunoturbidimetric method. This test is used in conjunction with other laboratory tests and clinical examinations to aid in the risk assessment of ill patients on their initial hospital admission for the potential development of sepsis and/ or septic shock.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : PTF

Prescription Use : Yes

Device Count : 1

Procalcitonin (PCT) Calibrators - 00657498001967 Catalog Number : 2310-601

Device Description : The Stanbio Procalcitonin (PCT) Calibrator Set is intended for use in the calibr The Stanbio Procalcitonin (PCT) Calibrator Set is intended for use in the calibration of the quantitative Stanbio PCT LiquiColor® Assay.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : PTF

Prescription Use : Yes

Device Count : 1

Procalcitonin (PCT) Bi-Level Controls - 00657498001974 Catalog Number : 2320-203

Device Description : The Stanbio Procalcitonin (PCT) Control Set is intended for use as quality contr The Stanbio Procalcitonin (PCT) Control Set is intended for use as quality control in examining the accuracy and precision of the quantitative Stanbio Procalcitonin (PCT) LiquiColor® Assay.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : PTF

Prescription Use : Yes

Device Count : 1

Uri-Trak 120 Analyzer Refurbished - 00657498001981 Catalog Number : G1200-001R

Device Description : The Uri-Trak™ 120 Urine Analyzer is intended for use in conjunction with Stanbio The Uri-Trak™ 120 Urine Analyzer is intended for use in conjunction with Stanbio Uri-Chek™ and Uri-Con™ 10 Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, and Leukocytes, as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : No

Product Code : KQO

Prescription Use : Yes

Device Count : 1

Hgb Control, Low - 00657498002018 Catalog Number : 3060-101L

Device Description : A single level reference control intended for use on HemoPoint® H2 Hemoglobin te A single level reference control 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

Hgb Control, Normal - 00657498002025 Catalog Number : 3060-101N

Device Description : A single level reference control intended for use on HemoPoint® H2 Hemoglobin te A single level reference control 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

Hgb Control, High - 00657498002032 Catalog Number : 3060-101H

Device Description : A single level reference control intended for use on HemoPoint® H2 Hemoglobin te A single level reference control 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

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