International Medical Devices Database

Manufacturer Address
Thera Test Laboratories, Inc., 1111 N Main St, Lombard IL 60148-1360
Source
USFDA
2 Events
- Recall of Device Recall RF IgA Calibrator
- Recall of Device Recall ELaCL AntiCardiolipin ELISA Kit

2 devices in the database

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).

Device Recall ELaCL AntiCardiolipin ELISA Kit

Model / Serial
catalog #201-204: kit lot 09055514, exp. 14-JUL-2006, serum diluent lot 09055546, exp 04-OCT-2006; and kit lot 12055603, exp. 09-NOV-2006, serum diluent lot 11055595, exp. 18-NOV-2007
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
California, Connecticut, Maryland, Pennsylvania, Ohio, New Jersey and Florida.
Product Description
EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #201-204; Thera Test Laboratories Inc., 1111 North Main Street, Lombard, IL 60148

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Thera Test Laboratories, Inc.

2 devices in the database

Device Recall RF IgA Calibrator

Device Recall ELaCL AntiCardiolipin ELISA Kit