Identity
- Trade Name
- EliA IgA Calibrators FDA UDI
- Generic Name
- Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Contains one vial of each Calibrator (Cal-0, Cal-0.3, Cal-1.5, Cal-5, Cal-15, Cal-80) to form a complete calibration curve for EliA IgA method. FDA UDI
- Model / Reference
- 83-1013-01 FDA UDI
- Description
- Contains one vial of each Calibrator (Cal-0, Cal-0.3, Cal-1.5, Cal-5, Cal-15, Cal-80) to form a complete calibration curve for EliA IgA method. FDA UDI
Identifiers
- Catalog Number
- 83-1013-01 FDA UDI
- Primary DI / UDI-DI
- 07333066020075 FDA UDI
- 510(k) Number
- K062787 FDA UDI
- FDA Product Code
- MVM FDA UDI
- GMDN Term
- Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 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 A (IgA total) IVD, kit, enzyme immunoassay (EIA)
EliA IgA Calibrators by Phadia GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total immunoglobulin A (IgA total) IVD, kit, enzyme immunoassay (EIA).
- EliA IgA Conjugate — Phadia GmbH · Class II
- EliA IgA Curve Control — Phadia GmbH · Class II
- ImmunoCAP Specific IgA Calibrators — Phadia GmbH · Class II
- ImmunoCAP Specific IgA Conjugate — Phadia GmbH · Class II
- ImmunoCAP Specific IgA Curve Controls — Phadia GmbH · Class II
Cleared under the same submission
K062787 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 II | Pending data |
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Manufacturer
- Manufacturer
- Phadia GmbH
Sources (1)
- FDA UDI c08fd17e-7dba-4998-844e-01d86820722c 37 fields · synced May 30, 2026