STANBIO LABORATORY, L.P.

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

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- Catalog Number : 6300-020

Device Description : For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylor For the Qualitative Detection of IgG Antibodies to Helicobacter pylori (H. pylori) in Whole blood, Serum or Plasma.

Device Class :

Duns Number: 045361136

Premarket Exempt : No

Product Code : LYR

Prescription Use : Yes

Device Count : 20

- Catalog Number : 6200-020

Device Description : For the Qualitative Detection of Infectious Mononucleosis (IM) Heterophile Antib For the Qualitative Detection of Infectious Mononucleosis (IM) Heterophile Antibodies in Whole blood, Serum or Plasma.

Device Class :

Duns Number: 045361136

Premarket Exempt : No

Product Code : KTN

Prescription Use : Yes

Device Count : 20

- Catalog Number : 1280-100

Device Description : The Stanbio Uri-Chek™ 10SG Urinalysis Reagent Strips are for the qualitative and The Stanbio Uri-Chek™ 10SG Urinalysis Reagent Strips are for the qualitative and semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes.

Device Class :

Duns Number: 045361136

Premarket Exempt : No

Product Code : CDM

Prescription Use : Yes

Device Count : 100

- Catalog Number : G1200-001

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 : No

Device Count : 1

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 : Yes

Product Code : JIN

Prescription Use : Yes

Device Count : 1

Device Description : The STAT-Site® M β-HB Test is intended for the quantitative determination of th The STAT-Site® M β-HB Test is intended for the quantitative determination of the ketone body β-Hydroxybutyrate in serum or plasma using the STAT-Site® M β-HB Analyzer (Catalog #400400). The STAT-Site® M β-HB Test may be used with adults, infants, and children. For laboratory use only.

Device Class :

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : JIN

Prescription Use : Yes

Device Count : 40

Device Description : STAT-Site® Controls are intended to be used to verify the procedural reliability STAT-Site® Controls are intended to be used to verify the procedural reliability of the assay for β-hydroxybutyrate using STAT-Site® Mβ-HB Meter and Test Strips.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : JIN

Prescription Use : Yes

Device Count : 1

Device Description : The STAT-Site® Linearity Check is intended to be used to perform a linearity eva The STAT-Site® Linearity Check is intended to be used to perform a linearity evaluation of the STAT-Site® Mβ-HB Test Strips /KetoSite® Test Cards by making a series of dilutions using STAT-Site® Diluent (Catalog No. 202000). Both the STAT-Site® Mβ-HB Test Strips and KetoSite® Test Cards are used in the measurement of β-hydroxybutyrate with the STAT-Site® Mβ-HB and STAT-Site® Meter.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : JIN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 202000

Device Description : STAT-Site® Diluent is intended to be used with the STAT-Site® M β-HB Test Strips STAT-Site® Diluent is intended to be used with the STAT-Site® M β-HB Test Strips or KetoSite® Test Cards to dilute specimens containing high levels of β-hydroxybutyrate into the test range of 0 – 2 mM. Additionally, the diluent helps to eliminate possible matrix effects caused by interfering substances such as acetoacetate.

Device Class : 1

Duns Number: 045361136

Premarket Exempt : Yes

Product Code : JIN

Prescription Use : Yes

Device Count : 1

Device Description : The STAT-Site® M Hgb Meter is a dedicated reflectance photometer designed to acc The STAT-Site® M Hgb Meter is a dedicated reflectance photometer designed to accept only STAT-Site® M Hgb CODE Keys and STAT-Site® M Hgb Test Cards. This test system is intended for the quantitative determination of hemoglobin in the whole blood of adults, infants, and children in a physician’s office or other professional point-of-care setting.

Device Class : 2

Duns Number: 045361136

Premarket Exempt : No

Product Code : KHG

Prescription Use : Yes

Device Count : 1