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EliA IgM Calibrator Strips
EUDAMEDFDA UDIClass B (EU MDR)
Ref 83-1052-01
by Phadia AB
Identity
- Trade Name
- EliA IgM Calibrator Strips EUDAMEDEliA IgM Calibrator Strip FDA UDI
- Generic Name
- Total immunoglobulin M (IgM total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- EliA IgM Method reagents EUDAMEDEliA IgM Calibrator Strip FDA UDI
- Model / Reference
- 83-1052-01 EUDAMED83-0006-21 FDA UDI
- Description
- EliA IgM Calibrator Strip FDA UDI
Identifiers
- Catalog Number
- 83-0006-21 FDA UDI
- Primary DI / UDI-DI
- 07333066012971 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0090M9 EUDAMED
- 510(k) Number
- K091845 FDA UDI
- FDA Product Code
- JJY FDA UDI
- EMDN Code
- W0102010107 IMMUNOGLOBULIN M EUDAMED
- GMDN Term
- Total immunoglobulin M (IgM total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
EliA IgM Calibrator Strips by Phadia AB — Class B — 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 | 7333066BUDI0090M9 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Phadia AB
- EUDAMED SRN
- SE-MF-000014170
Sources (2)
- EUDAMED e72c9301-8320-4042-96ff-58a8f6dd7c94 61 fields · synced Jun 18, 2026
- FDA UDI 035a92ae-5372-4a08-8730-24025f8e830c 37 fields · synced May 29, 2026