International Medical Devices Database

Manufacturer Address
Thermo Biostar, Incorporated, 331 South 104th Street, Louisville CO 80027
Source
USFDA
2 Events
- Recall of Device Recall Rapid IVD test kit for Chlamydia antigen..
- Recall of Device Recall Rapid IVD test kit for Chlamydia antigen..

2 devices in the database

Device Recall Rapid IVD test kit for Chlamydia antigen..

Model / Serial
Catalog No. CHLINT, Lot No. 133354, 133174. Foreign distribution.
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide, and to France, New Zealand and Spain.
Product Description
Chlamydia OIA. For in vitro diagnostic use.

Device Recall Rapid IVD test kit for Chlamydia antigen..

Model / Serial
Catalog No. CHL30, Lot No. 132117, 132117A,133101
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide, and to France, New Zealand and Spain.
Product Description
Chlamydia OIA. For in vitro diagnostic use,

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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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Thermo Biostar, Incorporated

2 devices in the database

Device Recall Rapid IVD test kit for Chlamydia antigen..

Device Recall Rapid IVD test kit for Chlamydia antigen..