International Medical Devices Database

Manufacturer Address
Biokit U.S.A. Inc., 180 Hartwell Rd, Bedford MA 01730-2443
Manufacturer Parent Company (2017)
Werfenlife Sa.
Source
USFDA
2 Events
- Recall of Biokit and SureVue HSV2 Rapid Test
- Recall of Biokit and SureVue HSV2 Rapid Test

One device in the database

Biokit and SureVue HSV2 Rapid Test

Model / Serial
Batch M691 (expiry: 2010/09) Batch M699 (expiry 2010/12)
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
US (CA, FL, GA, IN, KY, MA, NY, VA) and UK
Product Description
Sure-Vue HSV-2 Rapid Test, Catalogue No: 23-046395. || 20 test Kit || In Vitro Diagnostic test for Herpes Simplex Virus 2

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Disclaimer

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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Biokit U.S.A. Inc.

One device in the database

Biokit and SureVue HSV2 Rapid Test