Identity
- Trade Name
- BD BACTEC™ MGIT™ 960 Supplement Kit FDA UDI
- Generic Name
- Blood culture broth kit IVD FDA UDI
- Device Name
- BD BACTEC™ MGIT™ 960 Supplement Kit FDA UDI
- Model / Reference
- 245124 FDA UDI
- Description
- BD BACTEC™ MGIT™ 960 Supplement Kit FDA UDI
Identifiers
- Catalog Number
- 245124 FDA UDI
- Primary DI / UDI-DI
- 00382902451242 FDA UDI
- 510(k) Number
- K974883 FDA UDI
- FDA Product Code
- MDB FDA UDI
- GMDN Term
- Blood culture broth kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood culture broth kit IVD
BD BACTEC™ MGIT™ 960 Supplement Kit by Becton Dickinson And Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K974883 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI d508761b-cae2-4bc9-828f-625a7b77ab71 37 fields · synced May 30, 2026