International Medical Devices Database

Manufacturer Address
Digene Corp, 1201 Clopper Rd, Gaithersburg MD 20878-4000
Source
USFDA
1 Event
- Recall of Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003.

One device in the database

Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing t...

Model / Serial
Lot number 6234, EXP 10/20/04
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Product was sold to medical facility clinical laboratories nationwide and a distributor in the United Kingdom.
Product Description
Digene Hybrid Capture System CMV DNA Test (version 2.0), packaged in a cardboard box containing test reagents for performing 60 tests. Digene Catalog #4403-2003.

One manufacturer with a similar name

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Digene Corp

Manufacturer Address
Digene Corp, 1201 Clopper Road, Gaithersburg MD 20878
Source
USFDA

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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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