Prame [epr20330]
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- PRAME [EPR20330], 6.0mL EUDAMEDPRAME [EPR20330] FDA UDI
- Generic Name
- Preferentially expressed antigen in melanoma (PRAME) IVD, antibody FDA UDI
- Device Name
- PRAME [EPR20330] EUDAMED
- Model / Reference
- AVI3252G EUDAMEDFDA UDIPRAME [EPR20330] EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847627025067 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270B325277 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
- GMDN Term
- Preferentially expressed antigen in melanoma (PRAME) IVD, antibody FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
Prame [epr20330] by Biocare Medical, Llc — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Preferentially expressed antigen in melanoma (PRAME) IVD, antibody.
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biocare Medical, Llc
Sources (2)
- FDA UDI 54700330-28bf-455b-9622-8bff9b60dd58 33 fields · synced Jul 11, 2026
- EUDAMED 4fc35cf4-4279-4770-8444-677eb537367c 61 fields · synced Jul 11, 2026