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STANBIO LABORATORY

Last updated September 17, 2026

Information

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

Catalogue (235)

Page 5 of 5

Device	Model / Reference	Registries	Class	Status
Stanbio Bilirubin Test Set	K810055	FDA 510(k)	Class II	Active
Fertitube Pregnancy Test #1120	K832867	FDA 510(k)	Class II	Active
Stanbio Syphilis Rpr Test, No. 1170	K880144	FDA 510(k)	Class II	Active
Cholesterol-Enzymatic Reagent Set	K831863	FDA 510(k)	Class I	Active
Stanbio Acetaminophen Test Set #0850	K801014	FDA 510(k)	Class II	Active
Alkaline Phosphatase Test Set	K772257	FDA 510(k)	Class II	Active
Stanbio Prostatic Acid Phosphatase Test	K800693	FDA 510(k)	Class II	Active
Stanbio Quick-Tell Monoclonal Indirect	K842544	FDA 510(k)	Class II	Active
Wide Range C-Reactive Protein (wr Crp) Assay	K041155	FDA 510(k)	Class II	Active
Chloride Test Set, Cat.# 0210	K781635	FDA 510(k)	Class II	Active
Stanbio Csf/Urine Total Protein Test Set	K902204	FDA 510(k)	Class I	Active
Qupid Plus E.r.	K020378	FDA 510(k)	Class II	Active
Stanbio Alkaline Phosphatase (liquicolor) Test Set	K941313	FDA 510(k)	Class II	Active
Bi-Level Acetaminophen-Salicylate Cnrl	K813349	FDA 510(k)	Class I	Active
Quan. Color. Deter. Of Serum Albumin	K771771	FDA 510(k)	Class II	Active
Stanbio Ast/Got (liqui-Uv) Test Set, Cat No. 9020	K932049	FDA 510(k)	Class II	Active
Unitized Enzymatic Glucose Test Set	K832159	FDA 510(k)	Class II	Active
Csf Total Protein Test Set #0340	K780110	FDA 510(k)	Class II	Active
Stanbio Laboratory Hemopoint H2 Dm Hemoglobin Measurement System	K090093	FDA 510(k)	Class II	Active
Creatinine Liquicolor	K050283	FDA 510(k)	Class II	Active
Barbiturate Test Set #0550-050	K823237	FDA 510(k)	Class II	Active
Stanbio Enzymatic Urea Nitrogen Determinat #2010	K893128	FDA 510(k)	Class II	Active
Direct Bilirubin Liquicolor And Total Bilirubin Liquicolor	K050266	FDA 510(k)	Class II	Active
Sr-Plus Direct Cholesterol Test	K780545	FDA 510(k)	Class I	Active
Iron Binding Capicity Model 0370	K781865	FDA 510(k)	Class I	Active
Rapet Crp	K974429	FDA 510(k)	Class II	Active
Urea Nitrogen (bun) Liqui-Uv	K962418	FDA 510(k)	Class II	Active
Creatine Kinase (ck)	K972155	FDA 510(k)	Class II	Active
Stanbio Y-Gt (liquicolor) Test Set	K941315	FDA 510(k)	Class I	Active
Stanbio Direct Uric Acid Test Set #0770	K800190	FDA 510(k)	Class I	Active
Stanbio Laboratory Sirrus Clinical Chemistry Analyzer	K042169	FDA 510(k)	Class I	Active
Fertitell Direct Pregnancy Test #1100	K832557	FDA 510(k)	Class II	Active
Direct Ldl Cholesterol Liquid Color And Stanbio Direct Hdl/Ldl Cholesterol Calibrator	K032936	FDA 510(k)	Class II	Active
Stanbio Alt/Gpt (luqui-Uv) Test Set	K941314	FDA 510(k)	Class I	Active
Stanbio Alpha-Amylase Test Set, Catalog 0180-715	K870746	FDA 510(k)	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.