Identity
- Trade Name
- ImmunoCAP Specific 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 Specific IgA Calibrator (Cal-0.01, Cal-0.02, Cal-0.04, Cal-0.1, Cal-0.3, Cal-1.0) to form a complete calibration curve for the ImmunoCAP Specific IgA method. FDA UDI
- Model / Reference
- 10-9304-01 FDA UDI
- Description
- Contains one vial of each Specific IgA Calibrator (Cal-0.01, Cal-0.02, Cal-0.04, Cal-0.1, Cal-0.3, Cal-1.0) to form a complete calibration curve for the ImmunoCAP Specific IgA method. FDA UDI
Identifiers
- Catalog Number
- 10-9304-01 FDA UDI
- Primary DI / UDI-DI
- 07333066019550 FDA UDI
- 510(k) Number
- K052793 FDA UDI
- FDA Product Code
- MST 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
- 866.5750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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)
ImmunoCAP Specific 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 Calibrators — Phadia GmbH · Class II
- EliA IgA Conjugate — Phadia GmbH · Class II
- EliA IgA Curve Control — 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
K052793 also covers:
- ImmunoCAP Antigen AGf98, Gliadin — Phadia GmbH
- ImmunoCAP Gliadin IgA Control High — Phadia GmbH
- ImmunoCAP Gliadin IgA/IgG Control Low — Phadia GmbH
- ImmunoCAP Gliadin IgG Control High — Phadia GmbH
- ImmunoCAP Specific IgA Conjugate — Phadia GmbH
- ImmunoCAP Specific IgA Curve Controls — Phadia GmbH
- ImmunoCAP Specific IgA/IgG Sample Diluent — Phadia GmbH
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 7fdceef8-af6d-41dc-8d40-64397f4717ba 37 fields · synced May 30, 2026