Identity
- Trade Name
- VERSATREK 240 W/10 DR/CTRL MOD 220V FDA UDI
- Generic Name
- Blood culture analyser IVD FDA UDI
- Model / Reference
- Y24010220 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848838096556 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 240 W/10 Dr/Ctrl Mod 220v by Remel, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Remel, Inc.
Sources (1)
- FDA UDI d990d25a-a85a-4f22-a4bd-dc187eafba83 32 fields · synced Jun 8, 2026