Devices

Device Recall Sterling Diagnostics, Inc., Creatinine/Endpoint Modified HeinegardTiderstrom

Model / Serial
Creatinine/Endpoint [Modified Heinegard-Tiderstrom], CAT No. 2167-O, Lot No. 16751, Expriry: 5/18, Manufactured: 06/02/15
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Domestic: MI Foreign: Phillipines VA/DOD: None
Product Description
Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.
Manufacturer
Sterling Diagnostics, Inc.
1 Event
- Recall of Device Recall Sterling Diagnostics, Inc., Creatinine/Endpoint Modified HeinegardTiderstrom

Manufacturer

Sterling Diagnostics, Inc.

Manufacturer Address
Sterling Diagnostics, Inc., 36645 Metro Ct, Sterling Heights MI 48312-1009
Manufacturer Parent Company (2017)
Sterling Diagnostics Inc
Source
USFDA

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