Identity
- Trade Name
- AIM-V Medium EUDAMEDFDA UDI
- Generic Name
- Cell culture medium IVD FDA UDI
- Device Name
- AIM-V Medium EUDAMEDAIM-V® serum free cell culture medium is intended for use in the preparation of peripheral blood mononuclear cells (PBMCs) from whole blood and for use as a culture medium for in vitro testing using the ELISPOT method. PBMCs, separated from whole blood samples, are washed with AIM-V medium and the cell pellet is re-suspended in the medium. The cells are counted using a haemocytometer or automated cell counter before being diluted to the required concentration in AIM-V. FDA UDI
- Model / Reference
- AV.200/50 (A18398SA) EUDAMEDAV.200/50 FDA UDI
- Description
- AIM-V® serum free cell culture medium is intended for use in the preparation of peripheral blood mononuclear cells (PBMCs) from whole blood and for use as a culture medium for in vitro testing using the ELISPOT method. PBMCs, separated from whole blood samples, are washed with AIM-V medium and the cell pellet is re-suspended in the medium. The cells are counted using a haemocytometer or automated cell counter before being diluted to the required concentration in AIM-V. FDA UDI
Identifiers
- Catalog Number
- AV.200/50 FDA UDI
- Primary DI / UDI-DI
- 05051716000162 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05051716000162 EUDAMED
- FDA Product Code
- KZI FDA UDI
- EMDN Code
- W0580 IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES EUDAMED
- GMDN Term
- Cell culture medium IVD FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2330 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Prescription Use
No
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
AIM-V Medium by Oxford Immunotec Ltd — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05051716000162 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Oxford Immunotec Ltd
- EUDAMED SRN
- GB-MF-000004429
- Authorised Representative
- Wallac Oy FI-AR-000044744
Sources (2)
- EUDAMED 7d741bce-404e-4ba9-a163-5ba383e4f27f 61 fields · synced Jul 21, 2026
- FDA UDI 3850a576-5262-407e-ad51-1a2bcb21ac11 34 fields · synced May 30, 2026