Wiener Laboratorios S.A.I.C.
ROSARIO Santa Fe, AR
WIENER LABORATORIOS S.A.I.C. appears in FDA device records in ROSARIO Santa Fe, AR. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Wiener Laboratorios S.A.I.C. in 2009.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8040374 | 5864 | WIENER LABORATORIOS S.A.I.C. | 2571 Maipu, ROSARIO Santa Fe 2000 AR | 2026 | and 40 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CER2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase
- JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
- CHDAcid, Ferric Ion-Sulfuric, Cholesterol
- KNKAcid, Uric, Uricase (Colorimetric)
- DCFAlbumin, Antigen, Antiserum, Control
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- MSJApolipoproteins
- CJYAzo Dye, Calcium
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- CEKBiuret (Colorimetric), Total Protein
- JIOBlood, Occult, Colorimetric, In Urine
- CIXBromcresol Green Dye-Binding, Albumin
- JIXCalibrator, Multi-Analyte Mixture
- JFJCatalytic Methods, Amylase
- JGYColorimetric Method, Triglycerides
- DIHColorimetry, Cholinesterase
- CICCresolphthalein Complexone, Calcium
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CIGDiazo Colorimetry, Bilirubin
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JFYEnzymatic Method, Creatinine
- MIUEnzyme Linked Immunosorbent Assay, T. Cruzi
- JMOFerrozine (Colorimetric) Iron Binding Capacity
- CGAGlucose Oxidase, Glucose
- CKDHydrazone Colorimetry, Alt/Sgpt
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- JGPLowry (Colorimetric), Total Protein
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- CETOlive Oil Emulsion (Turbidimetric), Lipase
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- JZJPrealbumin, Antigen, Antiserum, Control
- JRERefractometer For Clinical Use
- LJXTest, Urine Leukocyte
- JHNTurbidimetric Method, Lipoproteins
- JHWU.V. Method, Cpk Isoenzymes
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain