Identity
- Trade Name
- GammaZyme-B EUDAMEDFDA UDI
- Generic Name
- Bromelin immunohaematology reagent IVD FDA UDI
- Device Name
- GammaZyme-B EUDAMEDGammaZyme-B is used in one-stage enzyme test systems for blood group antibody detection. GammaZyme-B is a stabilized solution of bromelin, and this product is in a single vial configuration. FDA UDI
- Model / Reference
- 0007058 EUDAMEDFDA UDI
- Description
- GammaZyme-B is used in one-stage enzyme test systems for blood group antibody detection. GammaZyme-B is a stabilized solution of bromelin, and this product is in a single vial configuration. FDA UDI
Identifiers
- Catalog Number
- 0007058 FDA UDI
- Primary DI / UDI-DI
- 10888234000716 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823401W0103030307C001TE EUDAMED
- FDA Product Code
- KSK FDA UDI
- EMDN Code
- W0103030307 ENZYMES (E.G. BROMELIN / PAPAIN, ETC.) EUDAMED
- GMDN Term
- Bromelin 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
GammaZyme-B 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 | 88823401W0103030307C001TE | 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 bc438a90-f7e9-4ca1-a720-022173d1ca90 61 fields · synced Jun 18, 2026
- FDA UDI 9d5f0920-74a5-4b75-9b85-8752715c8602 37 fields · synced May 29, 2026