International Medical Devices Database

Manufacturer Address
Instrumentation Laboratory Co., 180 Hartwell Rd, Bedford MA 01730-2443
Manufacturer Parent Company (2017)
Werfenlife Sa.
Source
USFDA
2 Events
- Recall of HemosIL ReadiPlasTin
- Recall of Device Recall Instrumentation Labs Test Plasminogen

2 devices in the database

HemosIL ReadiPlasTin

Model / Serial
Lots: N1166235 and N0177760.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US Nationwide
Product Description
Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 || Product Usage: || HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.

Device Recall Instrumentation Labs Test Plasminogen

Model / Serial
Lot No. N0455811, Expiration Date 03/31/2017
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US Distribution and to the countries of : Canada, Argentina, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, Italy, Lithuania, Panama, Poland, Russia, Saudi Arabia, United Kingdom, and Venezuela.
Product Description
HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate

16 manufacturers with a similar name

Learn more about the data here

INSTRUMENTATION LABORATORY CO. || Importer: ROCHEM BIOCARE COLOMBIA S.A.

Manufacturer Parent Company (2017)
Werfenlife Sa.
Source
NIDFSINVIMA

Instrumentation Laboratory Co.

Manufacturer Address
Instrumentation Laboratory Co., 180 Hartwell Road, Bedford MA 01730-2443
Manufacturer Parent Company (2017)
Werfenlife Sa.
Source
USFDA

Instrumentation Laboratory Co.

Manufacturer Address
Instrumentation Laboratory Co., 113 Hartwell Avenue, Lexington MA 02173
Source
USFDA

Instrumentation Laboratory Co.

Manufacturer Address
Instrumentation Laboratory Co., 113 Hartwell Ave, Lexington MA 02421-3125
Source
USFDA

Instrumentation Laboratory Co.

Manufacturer Parent Company (2017)
Werfenlife Sa.
Source
ALIMSA

11 more

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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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