Identity
- Trade Name
- BD BACTEC™ MGIT™ 960 PZA Medium FDA UDI
- Generic Name
- Differential/selective broth culture medium IVD FDA UDI
- Device Name
- BD BACTEC™ MGIT™ 960 PZA Medium, 25 tests FDA UDI
- Model / Reference
- 245115 FDA UDI
- Description
- BD BACTEC™ MGIT™ 960 PZA Medium, 25 tests FDA UDI
Identifiers
- Catalog Number
- 245115 FDA UDI
- Primary DI / UDI-DI
- 30382902451151 FDA UDI
- 510(k) Number
- K021582 FDA UDI
- FDA Product Code
- MJA FDA UDI
- GMDN Term
- Differential/selective broth culture medium IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1640 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 7 Milliliter FDA UDI
Category: Differential/selective broth culture medium IVD
BD BACTEC™ MGIT™ 960 PZA Medium by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Differential/selective broth culture medium IVD.
- REMEL — REMEL, INC. · Class I
- Tryptic Soy Broth 15g/L - 5ml tube — Lonza Verviers · Class I
- REMEL — REMEL, INC. · Class I
- 3% w/v TSB - 50 L bag — Lonza Verviers · Class I
- TSB 3%:1 L bag SAMPLE — Lonza Verviers · Class I
- Tryptic Soy Broth 200L bag — Lonza Verviers · Class I
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · Class I
- REMEL — REMEL, INC. · Class I
Cleared under the same submission
K021582 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 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 91539cd2-2dcf-442b-a098-77ec7a11eb62 38 fields · synced May 29, 2026