INSTRUMENTATION LABORATORY

Manufacturer · United States

Tick registration holders or device types below to filter this page.

47registrations in Brazil
47currently valid
1registration holder
21device types
2003first registration

Brazilian registration holders

  • · latest 2026↗ 47

Device types

  • ↗ 11
  • ↗ 6
  • ↗ 3
  • ↗ 3
  • ↗ 3
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 2
  • ↗ 1
  • ↗ 1
  • ↗ 1
  • ↗ 1
  • ↗ 1

Registrations

ProductDevice typeClass HolderPublishedStatus
HemosIL Chromogenic Factor
80003610628
Coagulation factor IX II WERFEN MEDICAL LTDA 05/10/2026 Valid
Família GEM System Evaluator
80003610627
Combined parameters in one product - class III III WERFEN MEDICAL LTDA 27/07/2026 Until 27/07/2036
GEM Premier 7000 com iQM3
80003610620
Combined parameters in one product - class III III WERFEN MEDICAL LTDA 20/10/2025 Until 20/10/2035
GEM Premier 7000
80003610615
Analyzer for blood gases, ions or pH II WERFEN MEDICAL LTDA 07/04/2025 Valid
Família ACL TOP Série 70
80003610611
Hemostasis analyzer II WERFEN MEDICAL LTDA 06/01/2025 Valid
ACL TOP 970 CL
80003610612
Hemostasis analyzer II WERFEN MEDICAL LTDA 06/01/2025 Valid
Família GEM PREMIER ChemSTAT
80003610583
Analyzer for blood gases, ions or pH II WERFEN MEDICAL LTDA 31/08/2020 Valid
GEM Premier 5000 BG/LYTES/GL/COOX
80003610560
Blood gases III WERFEN MEDICAL LTDA 23/07/2018 Until 23/07/2028
HemosIL ReadiPlasTin
80003610530
Prothrombin time (PT) III WERFEN MEDICAL LTDA 14/08/2017 Until 14/08/2027
Família Hemosil Rivaroxaban
80003610519
Heparin II WERFEN MEDICAL LTDA 10/10/2016 Valid
HemosIL AcuStar D-Dimer
80003610503
D-dimer III WERFEN MEDICAL LTDA 29/06/2015 Until 29/06/2035
HemosIL AcuStar D-Dimer Controls
80003610504
D-dimer III WERFEN MEDICAL LTDA 29/06/2015 Until 29/06/2035
Hemosil D-Dímero 500
80003610443
D-dimer III WERFEN MEDICAL LTDA 01/12/2014 Until 01/12/2034
Hemosil D-Dímero HS 500 Controles
80003610425
D-dimer III WERFEN MEDICAL LTDA 22/09/2014 Until 22/09/2034
Hemosil D-Dímero Controles
80003610417
D-dimer III WERFEN MEDICAL LTDA 18/08/2014 Until 18/08/2034
Hemosil Hepatocomplex
80003610396
Coagulation factor X II WERFEN MEDICAL LTDA 07/07/2014 Valid
Cartuchos Gem Premier 4000 Pak com IQM – BG/HCT/COOX
80003610371
Combined parameters in one product - class III III WERFEN MEDICAL LTDA 10/02/2014 Until 10/02/2034
Hemosil Fator Diluente
80003610334
Buffers, diluents and other solutions for laboratory analysis I WERFEN MEDICAL LTDA 01/04/2013 Valid
HemosIL Plasminogênio
80003610317
Plasminogen II WERFEN MEDICAL LTDA 24/12/2012 Valid
Hemosil Heparina
80003610311
Antithrombin II WERFEN MEDICAL LTDA 28/05/2012 Valid
Cartuchos Gem Premier 4000 Pak com Bilirrubina – BG/ISE/COOX/BILI
80003610297
Combined parameters in one product - class II II WERFEN MEDICAL LTDA 06/02/2012 Valid
GEM® CVP 5 tBilli
80003610286
Bilirubin II WERFEN MEDICAL LTDA 11/07/2011 Valid
GEM PREMIER 3500
80003610284
Analyzer for blood gases, ions or pH II WERFEN MEDICAL LTDA 16/05/2011 Valid
Hemosil Dimero D HS 500
80003610280
D-dimer III WERFEN MEDICAL LTDA 16/08/2010 Until 16/08/2035
Hemosil Synthafax
80003610276
Activated partial thromboplastin time (aPTT) III WERFEN MEDICAL LTDA 13/07/2010 Until 13/07/2035
Cartuchos Gem Premier 4000 Pak com Bilirrubina – BG/ISE/GL/COOX/BILI
80003610275
Combined parameters in one product - class II II WERFEN MEDICAL LTDA 28/06/2010 Valid
Gem Premier 3500 Pak com IQM
80003610271
Combined parameters in one product - class II II WERFEN MEDICAL LTDA 23/06/2010 Valid
Gem Premier 3500 Pak com IQM
80003610272
Combined parameters in one product - class II II WERFEN MEDICAL LTDA 23/06/2010 Valid
HemosIL Heparina Líquida
80003610261
Heparin II WERFEN MEDICAL LTDA 14/06/2010 Valid
HemosIL Calibrador de Heparina
80003610263
Heparin II WERFEN MEDICAL LTDA 14/06/2010 Valid
HEMOSIL ELECTRACHROME FATOR VIII
80003610254
Coagulation factor-deficient plasma II WERFEN MEDICAL LTDA 19/04/2010 Valid
HEMOSIL ANTITROMBINA LÍQUIDA
80003610249
Antithrombin II WERFEN MEDICAL LTDA 15/03/2010 Valid
Gem CVP 3000 Nível 1
80003610250
Combined parameters in one product - class II II WERFEN MEDICAL LTDA 15/03/2010 Valid
Gem CVP 4000 Nível 1
80003610251
Combined parameters in one product - class II II WERFEN MEDICAL LTDA 15/03/2010 Valid
Gem CVP 3000 Nível 2
80003610252
Combined parameters in one product - class II II WERFEN MEDICAL LTDA 15/03/2010 Valid
Gem CVP 4000 Nível 2
80003610253
Combined parameters in one product - class II II WERFEN MEDICAL LTDA 15/03/2010 Valid
Hemosil Especial Teste Nível I
80003610200
Combined parameters in one product - class II II WERFEN MEDICAL LTDA 16/02/2009 Valid
HEMOSIL RECOMBIPLASTIN 2G
80003610194
Prothrombin time (PT) III WERFEN MEDICAL LTDA 24/11/2008 Until 24/11/2033
HemosIL Fibrinógeno-C
80003610182
Fibrinogen II WERFEN MEDICAL LTDA 28/01/2008 Valid
HEMOSIL FIBRINÓGENO - C XL
80003610160
Fibrinogen II WERFEN MEDICAL LTDA 19/03/2007 Valid
HEMOSIL HOMOCISTEINA
80003610161
Homocysteine II WERFEN MEDICAL LTDA 19/03/2007 Valid
HEMOSIL ANTIGENO FATOR DE VON WILLEBRAND
80003610136
Von Willebrand factor II WERFEN MEDICAL LTDA 06/02/2006 Valid
GEM PREMIER 3000
80003610118
Analyzer for general chemistry, hormones, drugs or proteins II WERFEN MEDICAL LTDA 14/03/2005 Valid
GEM CVP
80003610117
Combined parameters in one product - class II II WERFEN MEDICAL LTDA 22/02/2005 Valid
ENSAIO DE CONTROLE NORMAL DE HEMOSIL
80003610048
Combined parameters in one product - class II II WERFEN MEDICAL LTDA 19/12/2003 Valid
HEMOSIL APTT-SP
80003610045
Activated partial thromboplastin time (aPTT) III WERFEN MEDICAL LTDA 27/10/2003 Until 27/10/2033
IL TESTE EMULSAO DE REFERENCIA
80003610043
Solution for performance testing of equipment components I WERFEN MEDICAL LTDA 22/09/2003 Valid