Devices

Stratus CS Acute Care Troponin I TestPak

Model / Serial
lot# 239229002, EXP# 2/13/2010 lot# 239236002, EXP2/20/2010 lot# 239243002, EXP# 2/7/2010 lot# 239257002, EXP# 3/10/2010 lot# 239264002, EXP# 3/20/2010 lot# 239271002, EXP# 3/27/2010 lot# 239278002, EXP# 4/3/2010 lot# 239285002, EXP# 4/10/2010 lot# 239292002, EXP# 4/17/2010 lot# 239299002, EXP# 4/24/2010 lot# 239313002, EXP 5/8/2010 lot# 239334002, EXP 5/29/2010 lot# 239341002, EXP#6/5/2010 lot# 239362002, EXP# 6/26/2010
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
- Recall of Stratus CS Acute Care Troponin I TestPak

Manufacturer

Siemens Healthcare Diagnostics, Inc.

Manufacturer Address
Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

4 devices with a similar name

Learn more about the data here

Stratus CS Acute Care Troponin I TestPak

Model / Serial
Product Description
In-vitro diagnostics
Manufacturer
Siemens

Stratus CS Acute Care Troponin I TestPak

Model / Serial
CCTNI | 238070002, 238077002, 238084002, 238091002, 238105002, 238112002, 238119002, 238126002, 238133002, 238140002
Product Description
IVD: Troponin kit
Manufacturer
Siemens Healthcare Diagnostics Inc.

Stratus CS Acute Care Troponin I TestPak

Model / Serial
CCTNI
Product Description
IVD: Troponin kit
Manufacturer
Siemens Healthcare Diagnostics Inc.

Device Recall Stratus CS Acute Care Troponin I TestPak

Model / Serial
Catalog number CCTNI. Lot numbers: 238070002 exp 2008-09-06, 238077002 exp 2008-09-13, 238084002 exp 2008-09-20, 238091002 exp 2008-09-27, 238105002 exp 2008-10-11, 238112002 exp 2008-10-18, 238119002 exp 2008-10-25, 238126002 exp 2008-11-01, 238133002 exp 2008-11-08, and 238140002 exp 2008-11-15.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA, Singapore, Saudi Arabia, Japan, Germany, Canada, Bahrain, Australia, Korea, and India.
Product Description
Stratus CS Acute Care Troponin I TestPak, Catalog number CCTNI, in vitro diagnostic.
Manufacturer
Dade Behring, Inc.

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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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