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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 2 of 5

Device	Model / Reference	Registries	Class	Status
Sirrus® ALT/SGPT Liqui-UV®	S2930-600	FDA UDI	Class I	Active
Sirrus® Phosphorus Liqui-UV®	S0830-750	FDA UDI	Class I	Active
Sirrus® Total Iron LiquiColor®	S0370-600	FDA UDI	Class I	Active
RELY Mono	6200-020	FDA UDI	Class II	Unknown
Direct Glycohemoglobin (HbA1c)	0360-040	FDA UDI	Class II	Active
Procalcitonin (PCT) Bi-Level Controls	2320-203	FDA UDI	Class II	Unknown
Glucose Liqui-UV®	1060-500	FDA UDI	Class II	Active
Uric Acid LiquiColor®	1045-225	FDA UDI	Class I	Active
LDH Liqui-UV®	2940-500	FDA UDI	Class II	Active
Total Protein LiquiColor®	0250-500	FDA UDI	Class II	Active
Sirrus® Alpha-Amylase LiquiColor®	S2970-750	FDA UDI	Class II	Active
TDM/B-Hydroxybutyrate Bi-Level Controls	2465-605	FDA UDI	Class I	Active
Sirrus® Direct Bilirubin LiquiColor®	S0235-600	FDA UDI	Class II	Active
STAT-Site WB Dual Analyte Measurement System	7000-001	FDA UDI	Class II	Active
Direct Glycohemoglobin (HbA1c) Calibrator Set	0365-401	FDA UDI	Class II	Active
Cholesterol LiquiColor®	1010-225	FDA UDI	Class I	Active
Sirrus® Glucose Liqui-UV®	S1060-600	FDA UDI	Class II	Active
Hgb Control, Low	3060-101L	FDA UDI	Class I	Active
Urea Nitrogen (BUN) Test	0580-250	FDA UDI	Class II	Active
RaPET® CRP	1130-100	FDA UDI	Class II	Active
TRUE® 20 PLUS hCG	1440-050	FDA UDI	Class II	Active
Sirrus® Calcium LiquiColor®	S0155-750	FDA UDI	Class II	Active
Sirrus® Total Bilirubin LiquiColor®	S0230-600	FDA UDI	Class II	Active
Ser-T-Fy 1, Level 1 Control	G427-86	FDA UDI	Class I	Active
Phosphorus Liqui-UV®	0830-125	FDA UDI	Class I	Active
Sirrus® Direct Gylcohemoglobin (HbA1c)	S0360-200	FDA UDI	Class II	Active
a-Amylase LiquiColor®	2970-430	FDA UDI	Class II	Active
ISE Potassium Electrode	20270476	FDA UDI	Class II	Active
STAT-Site M Hgb Code Key	901010	FDA UDI	Class II	Unknown
Sirrus® LDH Liqui-UV®	S2940-600	FDA UDI	Class II	Active
Creatinine LiquiColor®	0430-500	FDA UDI	Class II	Active
CK-MB Liqui-UV®	2980-430	FDA UDI	Class II	Active
ALT/SGPT Liqui-UV®	2930-500	FDA UDI	Class I	Active
Triglyceride LiquiColor®	2100-430	FDA UDI	Class I	Active
ISE Reference Electrode	20270473	FDA UDI	Class II	Active
Bi-Level Hgb Controls	3065-201	FDA UDI	Class I	Active
Uri-Trak 120 Analyzer	G1200-001	FDA UDI	Class I	Active
Glucose LiquiColor®	1070-125	FDA UDI	Class II	Active
QuSTICK™ Strep A	6000-050	FDA UDI	Class I	Active
RaPET® RF	1155-100	FDA UDI	Class II	Active
Ketone Urine Controls	4020-005	FDA UDI	Class I	Active
TDM/B-Hydroxybutyrate Tri-Level Controls	2460-605	FDA UDI	Class I	Active
Excel® Chemistry Analyzer (Spanish)	G7700S-001	FDA UDI	Class I	Active
Standard 1	A469-97	FDA UDI	Class II	Unknown
Glycohemoglobin Pre-Fil	P350-050	FDA UDI	Class II	Active
Sirrus® AST/SGOT Liqui-UV®	S2920-600	FDA UDI	Class II	Active
Triglyceride LiquiColor®	2100-225	FDA UDI	Class I	Active
RPR (Syphilis) Tri-Level Controls	1175-305	FDA UDI	Class II	Active
Sirrus® Cuvette Detergent 2	2209-620	FDA UDI	N/A	Active
Glucose Standard (100 mg/dL)	1072-030	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.