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Devices
Device Recall PTS Panels CHOLGLU Test Strips
Model / Serial
Lot # A705 UDI (01)00381931765016(17)180813(10)A705
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England
Product Description
PTS Panels¿ CHOL+GLU Test Strips (REF 1765)
Manufacturer
Polymer Technology Systems, Inc.
1 Event
Recall of Device Recall PTS Panels CHOLGLU Test Strips
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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
Language
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