Is this your brand? Sign in to claim ownership.

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 1 of 5

Device	Model / Reference	Registries	Class	Status
HGB Controls - High	3063-003	FDA UDI	Class I	Active
STAT-Site M Hgb Cards	901025	FDA UDI	Class II	Unknown
QuPID® Plus hCG Pregnancy Test	1230-025	FDA UDI	Class II	Active
TRUE® 20 hCG	1430-050	FDA UDI	Class II	Active
Sirrus® Uric Acid LiquiColor®	S1045-750	FDA UDI	Class I	Active
Glycated Serum Protein (GSP) LiquiColor®	2350-062	FDA UDI	Class II	Unknown
Sodium Test	0140-050	FDA UDI	N/A	Active
Sirrus® Urea Nitrigen (BUN) Liqui-UV®	S2020-600	FDA UDI	Class II	Active
HemoPoint H2 DMS	G3500-001	FDA UDI	Class II	Unknown
RPR Quicktest	1170-500	FDA UDI	Class II	Active
Cholesterol LiquiColor®	1010-430	FDA UDI	Class I	Active
STAT-Site WB Blood Glucose Test Strips	7010-050	FDA UDI	Class II	Active
Acetaminophen Liquicolor®	2400-060	FDA UDI	Class II	Active
Chloride LiquiColor®	0210-250	FDA UDI	Class II	Active
Sirrus® Alkaline Phosphatase LiquiColor®	S2900-600	FDA UDI	Class II	Active
STAT-Site M B-HB Analyzer Pack	400400	FDA UDI	Class I	Active
ISE Sodium Electrode	20270474	FDA UDI	Class II	Active
Micro Protein (CSF/Urine) LiquiColor®	0345-212	FDA UDI	Class I	Active
HGB Controls - Low	3061-006	FDA UDI	Class I	Active
TDM/B-Hydroxybutyrate Linearity Standards	2450-604	FDA UDI	Class II	Active
Glycated Serum Protein Bi-Level Control Set	2370-401	FDA UDI	Class I	Unknown
STAT-Site WB Blood Glucose Test Strips	7010-100	FDA UDI	Class II	Active
QuPID® Plus Sample Pack	1230-003	FDA UDI	Class II	Active
STAT-Site Diluent	202000	FDA UDI	Class I	Active
STAT-Site M B-HB Strips	401010	FDA UDI	Class I	Active
Creatinine LiquiColor®	0420-500	FDA UDI	Class II	Active
Cholesterol Standard (200 mg/dL)	1012-030	FDA UDI	Class I	Active
Direct HDL Cholesterol LiquiColor®	0590-040	FDA UDI	Class I	Active
ISE Chloride Electrode	20270475	FDA UDI	Class II	Active
QuPID® Plus hCG	1230-050	FDA UDI	Class II	Active
Sirrus® Superwash	2210-720	FDA UDI	N/A	Active
Sirrus® Gamma-GT LiquiColor®	S2960-600	FDA UDI	Class I	Active
HGB Controls - Low	3061-003	FDA UDI	Class I	Active
STAT-Site M Hgb Analyzer Pack	900900	FDA UDI	Class II	Unknown
Nitro-tab Ketone Tablets	4000-100	FDA UDI	Class I	Active
Ser-T-Cal Multicalibrator	0550-605	FDA UDI	Class II	Active
Sirrus® ISE Calibrator 2	20270478	FDA UDI	Class II	Active
Direct HDL Cholesterol LiquiColor®	0590-500	FDA UDI	Class I	Active
Iron & Total Iron Binding Capacity (TIBC) Test	0370-110	FDA UDI	Class I	Active
Hgb Control, High	3060-101H	FDA UDI	Class I	Active
Glucose LiquiColor®	1070-500	FDA UDI	Class II	Active
Gamma-GT LiquiColor®	2960-500	FDA UDI	Class I	Active
TRUE® 20 PLUS hCG	1440-025	FDA UDI	Class II	Active
Sirrus® Total Protein LiquiColor®	S0250-750	FDA UDI	Class II	Active
STAT-Site M B-HB Code Key	401020	FDA UDI	Class I	Active
Total Bilirubin LiquiColor®	0240-080	FDA UDI	Class II	Active
RaPET® s-LE	1160-050	FDA UDI	Class II	Unknown
HDL Cholesterol Precipitating Reagent	0599-020	FDA UDI	Class I	Active
HGB Controls - Normal	3062-006	FDA UDI	Class I	Active
Direct LDL Cholesterol LiquiColor®	0710-080	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.