Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8040374

FEI Number

5864

Entity Name

WIENER LABORATORIOS S.A.I.C.

City/State/Country

ROSARIO Santa Fe, AR

Establishment Address

2571 Maipu, ROSARIO Santa Fe 2000, AR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

WIENER LABORATORIOS S.A.I.C. (Owner Number: 8040374)

Owner / Operator Contact Address

RioBamba 2944, Rosario, AR-NOTA 2000, AR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DIAZO COLORIMETRY, BILIRUBIN Fosfatemia UV AA GOT(AST)UV AA Liquida Calibrador A Plus ASO latex Directo Maxi, ASO Latex Turbitest AA NADH OXIDATION/NAD REDUCTION, ALT/SGPT CK-NAC UV AA Liquida, CK-NAC UV AA Uricostat Enzimatico AA Liquida CGA/GLUCOSE OXIDASE, GLUCOSE CK MB DS UV Unitest TG color GPO PAP liquida, TG color GPO PAP AA ALP 405 Cinetica Optimizada, ALP 405 AA Liquida Lipase AA Liquida Fer-color AA Mg-color AA 2,4-DINITROPHENYLHYDRAZINE, LACTATE DEHYDROGENASE Ca-Color AA Urea UV cinetica AA, Urea UV cinetica AA liquida CATALYTIC METHODS, AMYLASE Chagatest ELISA Recombinante v.3 Standatrol SE 2 Niveles Colinesterasa AA GPT (ALT) UV AA liquida, GPT (ALT) UV AA, GPT (ALT) UV Unitest Urine Strip APOLIPOPROTEINS Proti 2 reactivo EDTA-Cu Gamma G-Test Cinetica AA G-Test cinetica AA liquida LDH-L Apo A-I Turbitest AA, Apo B Turbitest AA Colestat Enzimatico AA, Colestat Enzimatico, Colestat Enzimatico AA Liquida

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2008-11-26
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2008-11-26
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2008-11-26
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2008-11-26
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2002-02-13
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	1985-06-14
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2008-11-26
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2008-11-26
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2008-11-26
JHW	U.V. Method, Cpk Isoenzymes	Clinical Chemistry	Class 2	862.1215	2008-11-26
JGY	Colorimetric Method, Triglycerides	Clinical Chemistry	Class 1	862.1705	1985-06-14
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2008-11-26
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2011-02-04
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2008-11-26
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2008-11-26
CER	2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	1985-06-14
CIC	Cresolphthalein Complexone, Calcium	Clinical Chemistry	Class 2	862.1145	2008-11-26
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2008-11-26
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2008-11-26
MIU	Enzyme Linked Immunosorbent Assay, T. Cruzi	Microbiology	Class 1	866.3870	2008-11-26
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-11-26
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2008-11-26
CKD	Hydrazone Colorimetry, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	1985-06-14
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2010-11-30
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2010-11-30
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2010-11-30
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2010-11-30
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2010-11-30
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2010-11-30
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2010-11-30
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2010-11-30
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2010-11-30
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2010-11-30
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2010-11-30
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2010-11-30
JGP	Lowry (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	1985-06-14
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	1999-10-27
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	1999-10-27
JHN	Turbidimetric Method, Lipoproteins	Clinical Chemistry	Class 1	862.1475	2011-02-04
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	1999-10-27

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: REGISTRAR CORP Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

WIENER LABORATORIOS S.A.I.C.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K223078	Siemens Healthcare Diagnostics, Inc.	Atellica® CH Diazo Direct Bilirubin (D_DBil)	2023-06-12
K852783	Advanced Biomedical Methods, Inc.	SGOT/ALT REAGENT	1985-07-22
K041905	Instrumentation Laboratory CO	HEMOSIL CALIBRATION PLASMA	2004-09-28
K081103	Siemens Healthcare Diagnostics, Inc.	LOCI THYROID CALIBRATOR WITH MODEL RC610	2008-05-23
K760096	Gamma Biologicals, Inc.	REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O	1976-08-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2014	Abbott Laboratories, Inc	1	Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine.
Z-0006-2015	ELITech Clinical Systems SAS Zone lndustrielle SEES France	2	ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
Z-0164-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Z-0378-06	Instrumentation Laboratory Co.	2	GEM PREMIER 3000
Z-2165-2011	Instrumentation Laboratory Co.	2	Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8040374. Last updated year: 2026. Please use registration number 8040374 when referencing this establishment in official correspondence.