Devices

Device Recall RF IgA Calibrator

Model / Serial
RF IgA Calibrator: component catalog number 12833, lot number 11118586, exp. 28 DEC 2012; EL-RF/3: kit catalog number 303-305, lot number 11118583, exp. 28 NOV 2012.
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution (US)
Product Description
RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest Laboratories, Lombard, IL 60148; component catalog #12833, kit catalog #303-305. The TheraTest EL-RF/3 is intended as an aid to the diagnosis of Rheumatoid Arthritis (RA).
Manufacturer
Thera Test Laboratories, Inc.
1 Event
- Recall of Device Recall RF IgA Calibrator

Manufacturer

Thera Test Laboratories, Inc.

Manufacturer Address
Thera Test Laboratories, Inc., 1111 N Main St, Lombard IL 60148-1360
Source
USFDA

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