Identity
- Trade Name
- BD Directigen™ Meningitis Combo Test Cards FDA UDI
- Generic Name
- Multiple meningitis-associated bacteria antigen IVD, kit, agglutination FDA UDI
- Device Name
- BD Directigen™ Meningitis Combo Test Cards FDA UDI
- Model / Reference
- 252480 FDA UDI
- Description
- BD Directigen™ Meningitis Combo Test Cards FDA UDI
Identifiers
- Catalog Number
- 252480 FDA UDI
- Primary DI / UDI-DI
- 00382902524809 FDA UDI
- FDA Product Code
- GTJ FDA UDI
- GMDN Term
- Multiple meningitis-associated bacteria antigen IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3390 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
BD Directigen™ Meningitis Combo Test Cards by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI 4b0401b9-0861-4fbf-aeb0-05b76486b985 37 fields · synced Jun 1, 2026