Identity
- Trade Name
- RESt (Rabbit Erythrocyte Stroma) EUDAMEDRESt FDA UDI
- Generic Name
- Immunoglobulin removal reagent IVD FDA UDI
- Device Name
- RESt (Rabbit Erythrocyte Stroma) EUDAMEDRESt (Rabbit Erythrocyte Stroma) is used to adsorb cold reactive autoagglutins such as anti-I, anti-H or anti-IH, for human serum or plasma to facilitate the resolution of serological complexities. RESt contains a saline suspension of rabbit erythrocyte stroma. This package configuration is eight (8) tube tests. FDA UDI
- Model / Reference
- 0057316 EUDAMEDFDA UDI
- Description
- RESt (Rabbit Erythrocyte Stroma) is used to adsorb cold reactive autoagglutins such as anti-I, anti-H or anti-IH, for human serum or plasma to facilitate the resolution of serological complexities. RESt contains a saline suspension of rabbit erythrocyte stroma. This package configuration is eight (8) tube tests. FDA UDI
Identifiers
- Catalog Number
- 0057316 FDA UDI
- Primary DI / UDI-DI
- 10888234001003 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823401W01030399C040005T EUDAMED
- FDA Product Code
- LSQ FDA UDI
- EMDN Code
- W0103030399 ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER EUDAMED
- GMDN Term
- Immunoglobulin removal reagent IVD FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 866.3500 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
RESt (Rabbit Erythrocyte Stroma) 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 | 88823401W01030399C040005T | 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 b3272bcc-8898-4d77-bc4f-2090ffcdbe12 61 fields · synced Jun 18, 2026
- FDA UDI d6fa89ae-a3fd-4bc1-9ab3-ed4ffac15755 36 fields · synced May 30, 2026