Devices

Device Recall Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator

Model / Serial
Product catalog number: A68827; Lots 1308006, 1308131, Expiry: March 28, 2015.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
US Distribution including CA.
Product Description
Single Analyte DAU Calibrator (5 mL) || Norbuprenorphine: Cutoff Calibrator; || IVD - for in vitro diagnostic use only; || Lin-Zhi International || Sunnyvale, CA || The Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator is used for qualitative and semi-qualitative calibration of the Lin-Zhi Internal, Inc. Buprenorphine (BUP) enzyme Immunoassay (REF # A53684) on the Synchron Clinical Analyzer
Manufacturer
Lin-Zhi International Inc
1 Event
- Recall of Device Recall Norbuprenorphine Drug of Abuse (DAU) cutoff Calibrator

Manufacturer

Lin-Zhi International Inc

Manufacturer Address
Lin-Zhi International Inc, 670 Almanor Ave, Sunnyvale CA 94085-3513
Manufacturer Parent Company (2017)
Lin-Zhi International Inc.
Source
USFDA

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