Identity
- Trade Name
- UltraCulture FDA UDI
- Generic Name
- Enriched broth culture medium IVD FDA UDI
- Model / Reference
- WVSP1104P20 FDA UDI
Identifiers
- Catalog Number
- WVSP1104P20 FDA UDI
- Primary DI / UDI-DI
- 00840075404224 FDA UDI
- FDA Product Code
- KIT FDA UDI
- GMDN Term
- Enriched broth culture medium IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.2220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Enriched broth culture medium IVD
UltraCulture by Lonza Walkersville, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Enriched broth culture medium IVD.
- BD BBL™ Trypticase™ Soy Broth — BECTON DICKINSON AND COMPANY · Class I
- Northeast Laboratory Services — Northeast Laboratory Services, Inc. · Class I
- AnaeroGRO — HARDY DIAGNOSTICS · Class I
- AnaeroGRO — HARDY DIAGNOSTICS · Class I
- AnaeroGRO — HARDY DIAGNOSTICS · Class I
- REMEL — REMEL, INC. · Class I
- AnaeroGRO — HARDY DIAGNOSTICS · Class I
- BD BBL™ Trypticase™ Soy Broth — BECTON DICKINSON AND COMPANY · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lonza Walkersville, Inc.
Sources (1)
- FDA UDI e572029a-e836-43f5-a895-c1edf8e17234 33 fields · synced Jun 8, 2026