International Medical Devices Database

14 devices in the database

CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (patient ...

Model / Serial
Catalog number 3116247 , Lots 591 and 619; Catalog # 1937642, Lot 600; and Catalog # 1937634, Lot 583. Extended to all lots with an expiration date of on or before March 1, 2005.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
United States, Australia, Austria, Belgium, Chile, Czech Republic, Greece, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland and the United Kingdom.
Product Description
CoaguChek brand PT Test Strips; U.S. catalog number 3116247 (professional use), 3116239 (patient self test), ex-U.S. catalog numbers 1937642 [packaged 48 strips per box] and 1937634 [packaged 12 strips per box].

Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, ce...

Model / Serial
All lots of reagent when used manually or on the Roche/Hitachi 902, 911, 912, 917 or Modular Analytics P module analyzers.
Distribution
United States, Canada and Germany
Product Description
Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.

Roche/Hitachi Tina-quant RF II

Model / Serial
All lots
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
United States
Product Description
Roche/Hitachi Tina-quant RF II; catalog # 3004902

Elecsys Troponin T STAT

Model / Serial
All lots
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
United States
Product Description
Elecsys Troponin T STAT; catalog number 2017423

Elecsys Troponin T

Model / Serial
All lots.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
United States
Product Description
Elecsys Troponin T; catalog number 2017644

9 more

2 manufacturers with a similar name

Learn more about the data here

Roche Diagnostics Corp.

Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
Source
USFDA

Roche Diagnostics Corp.

Manufacturer Address
Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46250-0416
Source
USFDA

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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