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Sign in to claim this brandSTANBIO LABORATORY
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1261 NORTH MAIN ST., Boerne, TX, 78006
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1616487
- DUNS Number
- —
Catalogue (235)
Page 4 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CK Liqui-UV® | 2910-430 | FDA UDI | Class II | Active |
| RaPET® ASO | 1125-050 | FDA UDI | Class I | Active |
| Sirrus® Triglyceride LiquiColor® | S2200-750 | FDA UDI | Class I | Active |
| Sirrus® Bicarbonate (CO2) LiquiColor® | S0190-750 | FDA UDI | Class II | Active |
| B-Hydroxybutyrate LiquiColor® | 2440-058 | FDA UDI | Class I | Active |
| Blood Glucose Control Solution | 7014-204 | FDA UDI | Class I | Active |
| Cyanmethemoglobin Standard (20 gm/dL @ 1:251 DILUTION) | 0325-006 | FDA UDI | Class II | Unknown |
| Sirrus® Direct LDL Cholesterol LiquiColor® | S0710-540 | FDA UDI | Class I | Active |
| QuSTICK™ Strep A | 6000-025 | FDA UDI | Class I | Active |
| STAT-Site WB B-Ketone Test Strips | 7020-025 | FDA UDI | Class I | Active |
| STAT-Site WB B-Ketone Test Strips | 7020-100 | FDA UDI | Class I | Active |
| RaPET® RF | 1155-050 | FDA UDI | Class II | Active |
| hCG Bi-Level Urine Controls | 1225-205 | FDA UDI | Class I | Active |
| Potassium Test | 0160-050 | FDA UDI | Class II | Active |
| STAT-Site Linearity Check | 303500 | FDA UDI | Class I | Active |
| Uri-Trak 120 Analyzer Refurbished | G1200-001R | FDA UDI | Class I | Active |
| LDH Liqui-UV® | 2940-430 | FDA UDI | Class II | Active |
| Alkaline Phosphatase LiquiColor® | 2900-430 | FDA UDI | Class II | Active |
| Direct Bilirubin LiquiColor® | 0235-450 | FDA UDI | Class II | Active |
| Sirrus® Albumin LiquiColor® | S0285-750 | FDA UDI | Class II | Active |
| Direct Glycohemoglobin (HbA1c) Control Set | 0355-201 | FDA UDI | Class II | Active |
| Sirrus® Probe Cleaner | 2211-600 | FDA UDI | N/A | Active |
| Direct HDL Cholesterol LiquiColor® | 0590-080 | FDA UDI | Class I | Active |
| Calcium (Arsenazo) LiquiColor® | 0155-225 | FDA UDI | Class II | Active |
| RaPET® ASO | 1125-100 | FDA UDI | Class I | Active |
| TRUE® 20 Sample Pack | 1430-003 | FDA UDI | Class II | Active |
| Standard 2 | A469-98 | FDA UDI | Class II | Unknown |
| CK-MB Test | 0980-103 | FDA UDI | Class II | Unknown |
| Glycated Serum Protein Calibrator Set | 2360-401 | FDA UDI | Class II | Unknown |
| hCG Tri-Level Serum Controls | 1235-305 | FDA UDI | Class I | Active |
| AST/SGOT Liqui-UV® | 2920-430 | FDA UDI | Class II | Active |
| Sirrus® Total Cholesterol LiquiColor® | S1010-750 | FDA UDI | Class I | Active |
| STAT-Site WB Blood Glucose Test Strips | 7010-025 | FDA UDI | Class II | Active |
| Gamma-GT LiquiColor® | 2960-430 | FDA UDI | Class I | Active |
| STAT-Site WB B-Ketone Test Strips | 7020-050 | FDA UDI | Class I | Active |
| Sirrus® Cuvette Detergent 1 | 2208-640 | FDA UDI | N/A | Active |
| Urea Nitrogen (BUN) Liqui-UV® | 2020-430 | FDA UDI | Class II | Active |
| n•x•t Microcuvette | 3025-050 | FDA UDI | Class II | Active |
| Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System | K032482 | FDA 510(k) | Class II | Active |
| Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System | K081719 | FDA 510(k) | Class II | Active |
| Enzymatic Triglycerides #2000 | K832444 | FDA 510(k) | Class I | Active |
| Quick-Tell Indirect Pregnancy Test | K832640 | FDA 510(k) | Class II | Active |
| Acetazyme, Stanbio Acetaminophen Proc/Test 0870 | K851278 | FDA 510(k) | Class II | Active |
| Dir. Quant. Color. Determ. Serum Creat. | K771856 | FDA 510(k) | Class II | Active |
| Stanbio Magnesium Test Set, Cat. No 0130 | K883170 | FDA 510(k) | Class I | Active |
| Rapet Rf | K974370 | FDA 510(k) | Class II | Active |
| Triglycerides Reagent Set | K831858 | FDA 510(k) | Class I | Active |
| Direct Hdl-Cholesterol Liquid Color; Direct Hdl/Ldl-Cholesterol Calibrator | K032932 | FDA 510(k) | Class I | Active |
| Stanbio Cab Total Iron Procedure, Liquicolor | K880467 | FDA 510(k) | Class I | Active |
| Uric-Acid Test Enzymatic Colorimetric | K831864 | FDA 510(k) | Class I | Active |
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 18, 2006 | Z-0074-2007 | — | terminated | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
| Sep 18, 2006 | Z-0076-2007 | — | terminated | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |
| Sep 18, 2006 | Z-0075-2007 | — | terminated | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. |