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FDA-Registered Company Profile for STANBIO LABORATORY
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FDA-Supplied Establishment Information: |
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Establishment Registration Number: |
1616487 |
Company Name: |
STANBIO LABORATORY |
Also Known As: |
BIOCHEMICAL TRADE
HORIZON DIAGNOSTICS
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Address: |
1261 NORTH MAIN ST. |
Address 2: |
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City: |
BOERNE |
State |
TX |
Zip / Postal Code: |
78006 |
County: |
KENDALL |
Country: |
US |
Establishment Operation Code(s): |
MM - Manufacturer
MR - Remanufacturer
RR - Repackager/Relabeller
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Establishment Status Code: |
A -
Active
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Year of Most Recent Initial or Annual Registration: |
2007 |
FDA-Supplied Owner/Operator Information: |
Owner/Operator Number: |
1616487 |
Company Name: |
STANBIO LABORATORY
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Address: |
1261 NORTH MAIN ST. |
Address 2: |
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City: |
BOERNE |
State: |
TX |
Zip / Postal Code: |
78006 |
Country: |
US |
Owner/Operator Phone: |
830-249-0772
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FDA-Supplied Official Correspondent Information: |
Official Correspondent Name: |
MR. KIRK JOHNSON |
Company Name: |
STANBIO LABORATORY |
Address: |
1261 NORTH MAIN ST. |
Address 2: |
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City: |
BOERNE |
State: |
TX |
Zip / Postal Code: |
78006 |
Country: |
US |
Official Corespondent Phone Number: |
830-249-0772
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Other Establishment Information: |
Establishment Phone: |
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Fax: |
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General Email: |
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Web Site: |
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Company Brochure: |
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Keywords: |
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Company Description: |
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Services Offered: |
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About Us: |
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Differentiation: |
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FDA-Registered Products Offered by STANBIO LABORATORY
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Common Device Name |
Proprietary Device Name |
1 |
AMPHETAMINE DRUG OF ABUSE TEST |
EZ-SCREEN MULTIDRUG-6 INTEGRATED CUP |
2 |
AUTOMATED URINALYSIS SYSTEM |
URI-TRAK 100 |
3 |
BENZODIAZIPINE DRUG OF ABUSE TEST |
EZ-SCREEN MULTIDRUG-6 INTEGRATED CUP |
4 |
BROMCRESOL GREEN PROCEDURE FOR ALBUMIN |
BCG ALBUMIN REAGENT |
5 |
CALIBRATOR |
WR CRP CALIBRATOR |
6 |
CALIBRATOR |
ISE CALIBRATOR 1; ISE CALIBRATOR 2 |
7 |
CHEMISTRY ANALYZER |
SIRRUS CLINICAL CHEMISTRY ANALYZER |
8 |
CHLORIDE TEST SYSTEM |
ISE CHLORIDE ELECTRODE |
9 |
CLASSICAL BIURET PROCEDURE FOR TOTAL PROTEIN |
TOTAL PROTEIN REAGENT |
10 |
CLASSICAL LIEBERMAN-BURCHARD CHOLESTEROL REAGENT |
CHOLESTEROL REAGENT |
11 |
COCAINE DRUG OF ABUSE TEST |
EZ-SCREEN MULTIDRUG-6 INTEGRATED CUP |
12 |
COPPER SULFATE - ACID REAGENT FOR COLORIMETRIC DETERMINATION OF GLOBULIN |
GLOBULIN REAGENT (SEE ATTACHED DESCRIPTIVE MATERIAL) |
13 |
CREATININE TEST |
CREATININE LIQUICOLOR |
14 |
CRP TEST |
WR C-REACTIVE PROTEIN (WR CRP) ASSAY |
15 |
DIACETYL MONOXIME/THIOSEMICARBAZIDE PROCEDURE FOR UREA NITROGEN |
UREA NITROGEN TEST SET |
16 |
DIAZO PROCEDURE FOR TOTAL AND DIRECT BILIRUBIN |
BILIRUBIN TEST SET |
17 |
DIRECT BILIRUBIN, TOTAL BILIRUBIN |
DIRECT BILIRUBIN LIQUICOLOR, TOTAL BILIRUBIN LIQUICOLOR |
18 |
DIRECT HDL CHOLESTEROL |
DIRECT HDL CHOLESTEROL LIQUICOLOR |
19 |
DIRECT LDL CHOLESTEROL |
DIRECT LDL CHOLESTEROL LIQUICOLOR |
20 |
DIRECT QUANTITATIVE COLORMETRIC DETERMINATION OF PROSTATIC ACID PHOSPHATASE IN S |
PROSTATIC ACID PHOSPHATASE TEST SET, CAT. NO. 0910 |
21 |
DRABKIN'S PROCEDURE FOR COLORIMETRIC DETERMINATION OF HEMOGLOBIN |
CYANMETHEMOGLOBIN DILUENT POWDER, LIQUID REAGENT AND STANDAR |
22 |
EXTRACTION, PERIODATE OXIDATION, HANTSCH CONDENSATION PROCEDURE FOR TRIGLYCERIDE |
TRIGLYCERIDE TEST SET |
23 |
FEBRILE ANTIGENS |
FEBRILE ANTIGENS |
24 |
FILTER PHOTOMETER |
PREMIERE PLUS |
25 |
FRACTION V, BOVINE ALBUMIN, STABLE PROTEIN STANDARD (10 GM/D1) |
TOTAL PROTEIN STANDARD (SEE ATTACHED DESCRIPTIVE MATERIAL) |
26 |
H. PYLORI TEST |
RELY H. PYLORI TEST |
27 |
HEMOGLOBIN CONTROLS |
HEMOPOINT H2 HEMOGLOBIN CONTROLS |
28 |
HEMOGLOBIN TEST |
HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM |
29 |
HUMAN HEMOGLOBIN CONTROLS FOR QUANTITATIVE CYANMETHEMOGLOBIN |
STANBIO TRI-LEVEL HEMOGLOBIN CONTROL SET |
30 |
INFECTIOUS MONONUCLEOSIS TEST |
RELY INFECTIOUS MONONUCLEOSIS TEST |
31 |
MERCURIC THIOCYANATE PROCEDURE FOR CHLORIDE |
MULTIPLE (DIRECT AND FILTRATE PROCEDURES) |
32 |
METHAMPHETAMINE DRUG OF ABUSE TEST |
EZ-SCREEN MULTIDRUG-6 INTEGRATED CUP |
33 |
MODIFIED JAFFE (CREATININE ALKALINE PICRATE) PROCEDURE |
DIRECT CREATININE TEST SET |
34 |
MODIFIED ROMANOWSKY HEMATOLOGICAL STAIN SYSTEM |
MILES STAIN AND HEMATOLOGICAL BUFFER |
35 |
NO COMMON NAME LISTED |
NO PROPRIETARY NAME LISTED |
36 |
NO COMMON NAME LISTED |
NO PROPRIETARY NAME LISTED |
37 |
NO COMMON NAME LISTED |
NO PROPRIETARY NAME LISTED |
38 |
NO COMMON NAME LISTED |
NO PROPRIETARY NAME LISTED |
39 |
NO COMMON NAME LISTED |
NO PROPRIETARY NAME LISTED |
40 |
O-CRESOLPHTHALEIN COMPLEXONE PROCEDURE FOR TOTAL CALCIUM |
TOTAL CALCIUM TEST SET |
41 |
OCCULT BLOOD TEST |
HEMA-SCREEN |
42 |
ONE-STEP, QUALITATIVE, SANDWICH DYE CONJUGATE IMMUNOASSAY |
QUSTRIP HCG PREGNANCY TEST |
43 |
OPIATES DRUG OF ABUSE TEST |
EZ-SCREEN MULTIDRUG-6 INTEGRATED CUP |
44 |
ORTHO-TOLUIDINE, FROM NITRATE (SEE ATTACHED DESCRIPTIVE MATERIAL) |
ORTHO-TOLUIDINE, FROM NITRATE (SEE ATTACHED DESCRIPTIVE MATE |
45 |
PCP DRUG OF ABUSE TEST |
EZ-SCREEN MULTIDRUG-5PC INTEGRATED CUP |
46 |
PHOSPHOMOLYBDIC ACID PROCEDURE FOR INORGANIC PHOSPHOROUS |
INORGANIC PHOSPHOROUS TEST SET |
47 |
PHOSPHOTUNGSTATE/CARBONATE PROCEDURE FOR URIC ACID |
URIC ACID TEST SET |
48 |
POTASSIUM TEST SYSTEM |
ISE POTASSIUM ELECTRODE |
49 |
PREGNANCY TEST |
QUPID PLUS E.R. |
50 |
QUANTITATIVE COLORIMETRIC DETERMINATION OF AMYLASE ACTIVITY IN SERUM & URINE |
AMYLASE TEST SET CAT. NO. 0170 |
51 |
QUANTITATIVE COLORIMETRIC DETERMINATION OF GLYCOHEMOGLOBIN IN WHOLE BLOOD |
STANBIO GLYCOHEMOGLOBIN TEST SET |
52 |
QUANTITATIVE COLORIMETRIC DETERMINATION OF IRON & UNSATURATED IRON-BINDING |
IRON AND TOTAL IRON-BINDING CAPACITY TEST SET, CAT. NO. 0370 |
53 |
QUANTITATIVE COLORIMETRIC DETERMINATION OF MAGNESIUM IN SERUM OR URINE |
STANBIO MAGNESIUM TEST SET |
54 |
QUANTITATIVE COLORIMETRIC DETERMINATION OF TOTAL IRON IN SERUM |
STANBIO CAB:IRON LIQUICOLOR TEST SET |
55 |
QUANTITATIVE COLORMETRIC DETERMINATION OF TOTAL NEUTRAL 17-KETOSTEROIDS |
TOTAL 17-KETOSTEROIDS TEST SET, CAT. NO. 0700 |
56 |
QUANTITATIVE DETERMINATION OF ALANINE AMINOTRANSFERASE |
ALT/SGPT TEST SET (COLORIMETRIC) |
57 |
QUANTITATIVE DETERMINATION OF CREATINE KINASE IN SERUM |
CK TEST SET (CREATINE KINASE - COLORIMETRIC) |
58 |
QUANTITATIVE DETERMINATION OF GLUTAMIC DOXALACETIC |
AST/SGOT |
59 |
QUANTITATIVE DETERMINATION OF LACTATE DEHYDROGENASE |
LDH TEST SET (COLORIMETRIC) |
60 |
QUANTITATIVE ENZYMATIC COLORIMETRIC DETERMINATION OF TRIGLYCERIDES IN SERUM OR P |
STANBIO TRIGLYCERIDE TEST SET (ENZYMATIC), LYPHILIZED AND LIQUID. |
61 |
QUANTITATIVE ENZYMATIC COLORIMETRIC DETERMINATION OF URIC ACID IN SERUM, PLASMA |
STANBIO URIC ACID TEST SET (ENZYMATIC) - LYOPHILIZED AND LIQUID. |
62 |
QUANTITATIVE FULLY ENZYMATIC DETERMINATION OF SERUM OR PLASMA |
STANBIO ENZYMATIC CHOLESTEROL TEST SET |
63 |
QUANTITATIVE KINETIC DETERMINATION OF AMYLASE IN SERUM OR URINE, BLOCKED PNP-MA |
ALPHA-AMYLASE TEST SET (ENSYMATIC) |
64 |
QUANTITATIVE TURBIDIMETRIC DETERMINATION OF PROTEIN IN CEREBROSPINAL FLUID AND U |
CSF CEREBROSPINAL FLUID TOTAL PROTEIN TEST SET, CAT. NO. 034 |
65 |
QUANTITATIVE UV DETERMINATION OF BICARBONATE IN SERUM |
STABIO CO2 (BICARBONATE)TEST SET |
66 |
SINGLE ANALYTE CONTROLS |
WR CRP CONTROLS |
67 |
SODIUM TEST SYSTEM |
ISE SODIUM ELECTRODE |
68 |
STANBIO BARBITURATE TEST SET |
STANBIO BARBITURATE TEST SET |
69 |
STANBIO BI-LEVEL ACETAMINOPHEN-SALICYLATE CONTROL SET |
STANBIO BI-LEVEL ACETAMINOPHEN-SALICYLATE CONTROL SET |
70 |
STREP A TEST |
QUSTRIP STREP A |
71 |
TETRAPHENYL BORATE TURBIDIMETRIC POTASSIUM PROCEDURE |
POTASSIUM TEST SET |
72 |
THC DRUG OF ABUSE TEST |
EZ-SCREEN MULTIDRUG-6 INTEGRATED CUP |
73 |
THYMOLPHTHALEIN MONOPHOSPHATE PROCEDURE FOR ALKALINE PHOSPHATASE |
TMP ALKALINE PHOSPHATASE TEST SET, CAT. NO. 0900 |
74 |
TRINDER PROCEDURE FOR COLORIMETRIC DETERMINATION OF SALICYLATE |
SALICYLATE TEST SET |
75 |
URANYL ZINC ACETATE COLORIMETRIC PROCEDURE FOR SODIUM |
SODIUM TEST SET |
76 |
URINARY BILIRUBIN |
URI-QUICK 10SG |
77 |
URINARY BLOOD |
URI-QUICK 10SG |
78 |
URINARY GLUCOSE |
URI-QUICK 10SG |
79 |
URINARY KETONES |
URI-QUICK 10SG |
80 |
URINARY LEUKOCYTE |
URI-QUICK 10SG |
81 |
URINARY NITRITES |
URI-QUICK 10SG |
82 |
URINARY PH |
URI-QUICK 10SG |
83 |
URINARY PROTEIN |
URI-QUICK 10SG |
84 |
URINARY UROBILINOGEN |
URI-QUICK 10SG |
All FDA-Registered products for this company are displayed above. |