STANBIO LABORATORY

FDA Device Registration & Listing · Boerne, TX, US · Registration 1616487

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1616487
FEI Number
1616487
Entity Name
STANBIO LABORATORY
City/State/Country
Boerne, TX, US
Establishment Address
1261 NORTH MAIN ST., Boerne, TX 78006, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
STANBIO LABORATORY (Owner Number: 1616487)
Owner / Operator Contact Address
1261 NORTH MAIN ST., --, Boerne, TX 78006, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CFR Hexokinase, Glucose Clinical Chemistry Class 2 862.1345 2015-08-28
GKF Instrument, Hematocrit, Automated Hematology Class 2 864.5600 2017-01-23
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2010-12-29
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2015-03-13
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2015-03-13
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2018-08-22
DCF Albumin, Antigen, Antiserum, Control Immunology Class 2 866.5040 2018-04-05
GKG Centrifuge, Hematocrit Hematology Class 2 864.6400 2018-04-05
LDP Colorimetry, Acetaminophen Clinical Toxicology Class 2 862.3030 2014-02-11
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2017-01-23
JFJ Catalytic Methods, Amylase Clinical Chemistry Class 2 862.1070 2015-03-13
DIF Drug Mixture Control Materials Clinical Toxicology Class 1 862.3280 2018-04-15
JHW U.V. Method, Cpk Isoenzymes Clinical Chemistry Class 2 862.1215 2015-03-13
GTQ Antistreptolysin - Titer/Streptolysin O Reagent Microbiology Class 1 866.3720 2010-12-29
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2005-11-01
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2005-11-01
DKB Calibrators, Drug Mixture Clinical Toxicology Class 2 862.3200 2018-04-05
CIC Cresolphthalein Complexone, Calcium Clinical Chemistry Class 2 862.1145 2015-08-27
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2015-03-16
DCN System, Test, C-Reactive Protein Immunology Class 2 866.5270 2013-08-21
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2015-03-13
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 1994-01-04
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 1994-01-04
CGZ Electrode, Ion-Specific, Chloride Clinical Chemistry Class 2 862.1170 1994-01-04
JGS Electrode, Ion Specific, Sodium Clinical Chemistry Class 2 862.1665 1994-01-04
CEM Electrode, Ion Specific, Potassium Clinical Chemistry Class 2 862.1600 1994-01-04
LDP Colorimetry, Acetaminophen Clinical Toxicology Class 2 862.3030 2011-12-30
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2011-01-05
GTY Antigens, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2015-03-16
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2005-08-23
CHJ Mercuric Thiocyanate, Colorimetry, Chloride Clinical Chemistry Class 2 862.1170 2015-03-13
JSG Culture Media, Non-Selective And Non-Differential Microbiology Class 1 866.2300 2021-03-12
LYR Helicobacter Pylori Microbiology Class 1 866.3110 2007-09-12
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2018-04-05
JFM Enzymatic Method, Bilirubin Clinical Chemistry Class 2 862.1110 2005-08-23
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2018-04-05
KHG Whole Blood Hemoglobin Determination Hematology Class 2 864.7500 2011-11-30
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2018-04-05
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2015-01-22
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2015-01-22
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2015-01-22
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use Clinical Chemistry Class 1 862.2300 2005-11-01
JQB Kinetic Method, Gamma-Glutamyl Transpeptidase Clinical Chemistry Class 1 862.1360 2018-04-05
JIY Photometric Method, Iron (Non-Heme) Clinical Chemistry Class 1 862.1410 2018-04-05
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 1992-12-07
KTN System, Test, Infectious Mononucleosis Immunology Class 2 866.5640 2007-09-12
KHG Whole Blood Hemoglobin Determination Hematology Class 2 864.7500 2021-06-08
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2021-06-08
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2014-09-14
CGX Alkaline Picrate, Colorimetry, Creatinine Clinical Chemistry Class 2 862.1225 2015-03-13
CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes Clinical Chemistry Class 2 862.1215 2015-03-13
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2011-11-30
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2011-11-30
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2011-11-30
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2011-11-30
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2011-11-30
KQO Automated Urinalysis System Clinical Chemistry Class 1 862.2900 2011-11-30
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2011-11-30
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2011-11-30
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2011-11-30
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2011-11-30
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2011-11-30
CEK Biuret (Colorimetric), Total Protein Clinical Chemistry Class 2 862.1635 1977-12-15
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2018-02-13
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use Clinical Chemistry Class 1 862.2160 2019-11-07
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2005-11-01
KNK Acid, Uric, Uricase (Colorimetric) Clinical Chemistry Class 1 862.1775 2018-04-05
CJY Azo Dye, Calcium Clinical Chemistry Class 2 862.1145 2015-03-13
DKJ Colorimetry, Salicylate Clinical Toxicology Class 2 862.3830 2011-12-30
GGM Control, Hemoglobin Hematology Class 2 864.8625 2018-02-14
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus Clinical Chemistry Class 1 862.1580 2018-04-05
JJW Urinalysis Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2018-04-05
JIX Calibrator, Multi-Analyte Mixture Clinical Chemistry Class 2 862.1150 2009-02-22
CGA Glucose Oxidase, Glucose Clinical Chemistry Class 2 862.1345 2015-03-13
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen Clinical Chemistry Class 2 862.1770 2015-03-16
GKR System, Hemoglobin, Automated Hematology Class 2 864.5620 2014-09-14
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Clinical Chemistry Class 2 862.1050 2010-12-29
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2023-05-04
JRE Refractometer For Clinical Use Clinical Chemistry Class 1 862.2800 2011-01-24
JMA Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) Clinical Chemistry Class 1 862.1095 2011-01-24
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2011-01-24
JIO Blood, Occult, Colorimetric, In Urine Hematology Class 2 864.6550 2011-01-24
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1115 2011-01-24
JIN Nitroprusside, Ketones (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1435 2011-01-24
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2011-01-24
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2011-01-24
CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1785 2011-01-24
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative) Clinical Chemistry Class 2 862.1340 2011-01-24
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2011-01-24
GIO Tube, Collection, Capillary Blood Hematology Class 1 864.6150 2017-01-23
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2015-03-16
KHE Reagent, Occult Blood Hematology Class 2 864.6550 2015-03-16
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Clinical Chemistry Class 1 862.1475 2018-04-05
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 1999-09-22
LDP Colorimetry, Acetaminophen Clinical Toxicology Class 2 862.3030 2014-03-19
CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt Clinical Chemistry Class 1 862.1030 1987-09-04
GLK Control, Hematocrit Hematology Class 2 864.8625 2018-04-05
CFJ Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase Clinical Chemistry Class 2 862.1440 1987-09-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STANBIO LABORATORY
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3017101757 EKF Life Sciences South Bend, IN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K761345 J.T. Baker Chemical Co. GLUCO-HEX TM REAGENT KIT 1977-01-05
K771464 Instrumentation Laboratory CO MULTISTAT III GLUCOSE TEST 1977-09-02
K920820 Helena Laboratories MODIFICATION COLUMNMATE 1992-08-17
K991850 Biosafe Laboratories, Inc. SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC 1999-11-26
K191454 Siemens Healthcare Diagnostics, Inc. Atellica CH Amylase_2 (AMY_2) 2019-07-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0017-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A1c in human whole blood. IVD Contents: 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer 2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer 3. Wash/Diluent 1 x 1600 mL Deionized water 4. Analytical cartridge - 1 cation exchange cartridge 5. Floppy Diskette 1-program parameters 6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water. 7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative. 8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid 9 Thermal paper - 1 roll 10. Instruction manual Made in United States Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0018-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0019-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0020-2012 Bio-Rad Laboratories, Inc. 2
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 4 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 2 vial each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0021-2012 Bio-Rad Laboratories, Inc. 2
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 5 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 3 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1616487. Last updated year: 2026. Please use registration number 1616487 when referencing this establishment in official correspondence.
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