Devices

Device Recall Sterling Diagnostics, Inc., Urea Nitrogen/Color BUN (Enzymatic Berthelot)

Model / Serial
Urea Nitrogen/Color BUN, CAT No. 2290-L , Lot No. 29051, Expriry: 9/18, Manufactured: 09/21/15
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Domestic: MI Foreign: Phillipines VA/DOD: None
Product Description
Urea Nitrogen/Color BUN (Enzymatic Berthelot) 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., Urea Nitrogen/Color BUN (Enzymatic Berthelot)

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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