Identity
- Trade Name
- EliA IgM Calibrators FDA UDI
- Generic Name
- Total immunoglobulin M (IgM total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Contains one vial of each Calibrator (Cal-0, Cal-10, Cal-35, Cal-80, Cal-500, Cal-1000) to form a complete calibration curve for EliA IgM method. FDA UDI
- Model / Reference
- 83-1049-01 FDA UDI
- Description
- Contains one vial of each Calibrator (Cal-0, Cal-10, Cal-35, Cal-80, Cal-500, Cal-1000) to form a complete calibration curve for EliA IgM method. FDA UDI
Identifiers
- Catalog Number
- 83-1049-01 FDA UDI
- Primary DI / UDI-DI
- 07333066020082 FDA UDI
- 510(k) Number
- K091845 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Total immunoglobulin M (IgM total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Total immunoglobulin M (IgM total) IVD, kit, enzyme immunoassay (EIA)
EliA IgM Calibrators by Phadia GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total immunoglobulin M (IgM total) IVD, kit, enzyme immunoassay (EIA).
- EliA IgM Curve Control — Phadia GmbH · Class I
- EliA IgM Conjugate — Phadia GmbH · Class I
Cleared under the same submission
K091845 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Phadia GmbH
Sources (1)
- FDA UDI c2f96dd6-b557-4a7f-a5a1-4001c791d44b 37 fields · synced May 30, 2026