Devices

CardioChek PTS panels

Model / Serial
Lot I891.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide.
Product Description
PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.
Manufacturer
Polymer Technology Systems, Inc.
1 Event
- Recall of CardioChek PTS panels

Manufacturer

Polymer Technology Systems, Inc.

Manufacturer Address
Polymer Technology Systems, Inc., 7736 Zionsville Rd, Indianapolis IN 46268-2175
Manufacturer Parent Company (2017)
Sinocare Inc.
Source
USFDA

One device with a similar name

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Device Recall CardioChek PTS Panels CHOLHDLGLU

Model / Serial
Lot number I904
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
US accounts in: CA, MA, FL, NY, KY, VA, UT, MN, OH, and MD. Direct foreign accounts in: Belgium, England, Sweden, and Italy.
Product Description
PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736 Zionsville Rd., Indianapolis, IN 46268.
Manufacturer
Polymer Technology Systems, 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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