Identity
- Trade Name
- NutriDetect™ 90G M IgG ELISA EUDAMEDAllerquant™ 90G ELISA EUDAMED
- Device Name
- NutriDetect™ 90G M IgG ELISA EUDAMEDAllerquant™ 90G M ELISA EUDAMED
- Model / Reference
- 7191 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00083059071917 EUDAMED
- Basic UDI-DI
- 00830597191JG EUDAMEDB-00083059071917 EUDAMED
- Direct Marketing DI
- 00083059071917 EUDAMED
- EMDN Code
- W01020208 ALLERGENE SPECIFIC IGG EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
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
NutriDetect™ 90G M IgG ELISA by Biomerica, Inc. — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 00830597191JG | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 00830597191JG | Class B | Active |
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Manufacturer
- Manufacturer
- Biomerica, Inc.
- EUDAMED SRN
- US-MF-000015772
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 83e58f09-3f90-40f6-8e69-b6c92c8f6c74 61 fields · synced Jul 18, 2026
- EUDAMED 95914fc0-fd91-4a61-bfd9-731e04e143ef 61 fields · synced May 18, 2026