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STANBIO LABORATORY

Last updated September 17, 2026

Information

Country: US
Address: 1261 NORTH MAIN ST., Boerne, TX, 78006
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1616487
DUNS Number: —

Catalogue (235)

Page 3 of 5

Device	Model / Reference	Registries	Class	Status
Glycated Serum Protein Linearity Set	2380-201	FDA UDI	Class I	Unknown
Hema-Screen Lab Pack	1290-100	FDA UDI	Class II	Active
Salicylate Liqui-UV®	2410-051	FDA UDI	Class II	Active
Ketone Serum Controls	4010-002	FDA UDI	Class I	Active
Sirrus® Direct HDL Cholesterol LiquiColor®	S0590-540	FDA UDI	Class I	Active
Reference Solution	A469-99	FDA UDI	Class II	Unknown
HGB Controls - High	3063-006	FDA UDI	Class I	Active
Procalcitonin LiquiColor	2300-060	FDA UDI	Class II	Unknown
Glycohemoglobin	0350-060	FDA UDI	Class II	Active
Alkaline Phosphatase LiquiColor®	2900-500	FDA UDI	Class II	Active
Magnesium LiquiColor®	0130-430	FDA UDI	Class I	Active
RaPET® CRP	1130-050	FDA UDI	Class II	Active
Ser-T-Fy 2, Level 2 Control	G428-86	FDA UDI	Class I	Active
RPR Quicktest	1170-100	FDA UDI	Class II	Active
Triglyceride LiquiColor® (Mono)	2200-430	FDA UDI	Class I	Active
HemoPoint® H2 n•x•t Microcuvettes	3016-050	FDA UDI	Class II	Active
Sirrus® ISE Wash Solution	20270479	FDA UDI	N/A	Active
Direct (HDL/LDL) Cholesterol Calibrator	0595-003	FDA UDI	Class I	Active
Calcium (CPC) LiquiColor®	0150-250	FDA UDI	Class II	Active
Synchron® CX/LX/DX B-Hydroxybutyrate LiquiColor®	B2440-180	FDA UDI	Class I	Active
STAT-Site Hgb Controls	503000	FDA UDI	Class II	Unknown
Total Bilirubin LiquiColor®	0230-450	FDA UDI	Class II	Active
Direct Bilirubin LiquiColor®	0245-250	FDA UDI	Class II	Active
RELY® H.Pylori	6300-020	FDA UDI	Class I	Unknown
Sirrus® ISE Calibrator 1	20270477	FDA UDI	Class II	Active
Albumin LiquiColor®	0285-500	FDA UDI	Class II	Active
Creatinine LiquiColor®	0430-120	FDA UDI	Class II	Active
QuPID® hCG	1220-050	FDA UDI	Class II	Active
Glucose LiquiColor®	1071-001	FDA UDI	Class II	Active
Uric Acid LiquiColor®	1045-430	FDA UDI	Class I	Active
Urea Nitrogen (BUN) Liqui-UV®	2020-500	FDA UDI	Class II	Active
Glycohemoglobin Bi-Level Controls	0357-201	FDA UDI	Class II	Active
Sirrus® CK Liqui-UV®	S2910-600	FDA UDI	Class II	Active
Uri-Chek 10SG Strips	1280-100	FDA UDI	Class I	Active
Total & Direct Bilirubin LiquiColor®	0260-200	FDA UDI	Class II	Active
QuPID® hCG	1220-025	FDA UDI	Class II	Active
STAT-Site B-HB Controls	303000	FDA UDI	Class I	Active
Sirrus® Magnesium LiquiColor®	S0130-600	FDA UDI	Class I	Active
B-Ketone Control Solution	7024-204	FDA UDI	Class I	Active
Sirrus® Creatinine LiquiColor®	S0430-600	FDA UDI	Class II	Active
Uri-Trak 120 M Urine Analyzer	G1300-001	FDA UDI	Class I	Active
Excel® Chemistry Analyzer	G7700E-001	FDA UDI	Class I	Active
HemoPoint H2	G3000-CONTCUV	FDA UDI	Class II	Active
HGB Controls - Normal	3062-003	FDA UDI	Class I	Active
Procalcitonin (PCT) Calibrators	2310-601	FDA UDI	Class II	Unknown
Triglyceride LiquiColor® (Mono)	2200-225	FDA UDI	Class I	Unknown
Hgb Control, Normal	3060-101N	FDA UDI	Class I	Active
Bi-Level Hgb Controls	3065-601	FDA UDI	Class I	Active
ALT/SGPT Liqui-UV®	2930-430	FDA UDI	Class I	Active
AST/SGOT Liqui-UV®	2920-500	FDA UDI	Class II	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.