Devices

Device Recall MultiAnalyte Urine DAU Cutoff Calibrator

Model / Serial
Catalog number 0803; Lot 1101136K3, exp 1/28/13
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) including states of: AL, FL, GA, IN, NC, NH, and TX; and country of: Germany.
Product Description
Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) || For in vitro diagnostic use only. || Lin-Zhi International, Inc.. || 670 Almanor Ave. || Sunnyvale, CA 94085 || intended use: Drug abuse detection.
Manufacturer
Lin-Zhi International Inc
1 Event
- Recall of Device Recall MultiAnalyte Urine 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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