Identity
- Trade Name
- VERSATREK M 528 W/22 DRAWERS FDA UDI
- Generic Name
- Blood culture analyser IVD FDA UDI
- Model / Reference
- Y52822M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848838096747 FDA UDI
- FDA Product Code
- MDB FDA UDI
- GMDN Term
- Blood culture analyser 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood culture analyser IVD
Versatrek M 528 W/22 Drawers by Remel, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood culture analyser IVD.
- BACT/ALERT® 3D LEFT COMBINATION MODULE — BIOMERIEUX , INC. · Class I
- BacT/ALERT®3D — BIOMERIEUX , INC. · Class I
- BD BACTEC™ FX Bottom — BECTON DICKINSON AND COMPANY · Class I
- BD BACTEC™ FX Top — BECTON DICKINSON AND COMPANY · Class I
- BACT/ALERT® VIRTUO® FIRMWARE R3.0 — BIOMERIEUX , INC. · Class I
- BACT/ALERT — BIOMERIEUX , INC. · Class I
- BD BACTEC™ MGIT™ 960 Instrument, Remanufactured — BECTON DICKINSON AND COMPANY · Class I
- BACT/ALERT® 3D LEFT INCUBATION MODULE — BIOMERIEUX , INC. · 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
- Remel, Inc.
Sources (1)
- FDA UDI e68fcf8c-1d4b-40b7-a663-c9eef7dfc2cc 32 fields · synced May 29, 2026