Identity
- Trade Name
- Freeze-Dried Papain EUDAMEDFreeze Dried Papain FDA UDI
- Generic Name
- Papain immunohaematology reagent IVD FDA UDI
- Device Name
- Freeze-Dried Papain EUDAMEDFreeze Dried Papain is used as a proteolytic enzyme in serological tests. The papain enzyme is derived from Carica papaya. The product configuration is ten (10) vials. FDA UDI
- Model / Reference
- 0057292 EUDAMEDFDA UDI
- Description
- Freeze Dried Papain is used as a proteolytic enzyme in serological tests. The papain enzyme is derived from Carica papaya. The product configuration is ten (10) vials. FDA UDI
Identifiers
- Catalog Number
- 0057292 FDA UDI
- Primary DI / UDI-DI
- 10888234000990 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823401W0103030307C002TG EUDAMED
- 510(k) Number
- K810803 FDA UDI
- FDA Product Code
- KSK FDA UDI
- EMDN Code
- W0103030307 ENZYMES (E.G. BROMELIN / PAPAIN, ETC.) EUDAMED
- GMDN Term
- Papain immunohaematology reagent IVD FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
New Device
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Freeze-Dried Papain by Immucor, Inc. — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 88823401W0103030307C002TG | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
- EUDAMED SRN
- US-MF-000011568
- Authorised Representative
- IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083
Sources (2)
- EUDAMED bea56c8a-2e2d-4ee8-a767-982df334a065 61 fields · synced Jun 18, 2026
- FDA UDI 088cb341-8b05-432e-b6fe-bcad7af99ebe 37 fields · synced May 30, 2026