Identity
- Trade Name
- Fresh Cells FDA UDI
- Generic Name
- Cell culture line IVD FDA UDI
- Device Name
- R-MIX TOO MWP W24/18F FDA UDI
- Model / Reference
- 97-2418 FDA UDI
- Description
- R-MIX TOO MWP W24/18F FDA UDI
Identifiers
- Catalog Number
- 97-2418 FDA UDI
- Primary DI / UDI-DI
- 30014613335122 FDA UDI
- FDA Product Code
- KIR FDA UDI
- GMDN Term
- Cell culture line IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.2280 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cell culture line IVD
Fresh Cells by Diagnostic Hybrids, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cell culture line IVD.
- Fresh Cells — DIAGNOSTIC HYBRIDS, INC. · Class I
- Fresh Cells — DIAGNOSTIC HYBRIDS, INC. · Class I
- Fresh Cells — DIAGNOSTIC HYBRIDS, INC. · Class I
- Fresh Cells — DIAGNOSTIC HYBRIDS, INC. · Class I
- Fresh Cells — DIAGNOSTIC HYBRIDS, INC. · Class I
- Fresh Cells — DIAGNOSTIC HYBRIDS, INC. · Class I
- Fresh Cells — DIAGNOSTIC HYBRIDS, INC. · Class I
- Fresh Cells — DIAGNOSTIC HYBRIDS, 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 |
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Manufacturer
- Manufacturer
- Diagnostic Hybrids, Inc.
Sources (1)
- FDA UDI feac3bbd-2d07-4fcf-9c58-7319b6f7f62b 35 fields · synced Jun 8, 2026