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W.A.R.M.(Warm Autoantibody Removal Medium)
EUDAMEDFDA UDIClass C (EU MDR)
Ref W.A.R.M. (Warm Autoantibody Removal Medium)
Identity
- Trade Name
- W.A.R.M. FDA UDI
- Generic Name
- Papain immunohaematology reagent IVD FDA UDI
- Device Name
- W.A.R.M.(Warm Autoantibody Removal Medium) EUDAMEDW.A.R.M. (Warm Autoantibody Removal Medium) is used for the removal of warm-reactive autoantibody from red blood cells to facilitate resolution of serological complexities. W.A.R.M. is a specially formulated preparation of dithiothreitol and cysteine-activated papain in a phosphate buffer. It has been filtered and lyophilized. This product must be reconstituted with deionized water and mixed thoroughly prior to use. The product configuration is ten (10) vials. FDA UDI
- Model / Reference
- W.A.R.M. (Warm Autoantibody Removal Medium) EUDAMED0057319 FDA UDI
- Description
- W.A.R.M. (Warm Autoantibody Removal Medium) is used for the removal of warm-reactive autoantibody from red blood cells to facilitate resolution of serological complexities. W.A.R.M. is a specially formulated preparation of dithiothreitol and cysteine-activated papain in a phosphate buffer. It has been filtered and lyophilized. This product must be reconstituted with deionized water and mixed thoroughly prior to use. The product configuration is ten (10) vials. FDA UDI
Identifiers
- Catalog Number
- 0057319 FDA UDI
- Primary DI / UDI-DI
- 10888234001010 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823401W0103030307C003TJ EUDAMED
- 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
No
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
W.A.R.M.(Warm Autoantibody Removal Medium) 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 | 88823401W0103030307C003TJ | 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 9c759d1e-a7d0-415f-81fc-8a40408ddcf2 61 fields · synced Jul 21, 2026
- FDA UDI 87029884-80ed-477a-a397-63ba7170f6a5 37 fields · synced May 30, 2026