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ImmunoCAP Specific IgG, Antigen tp, Thyroid Peroxidase
FDA UDIClass II (US FDA UDI)
by Phadia GmbH
Identity
- Trade Name
- ImmunoCAP Specific IgG, Antigen tp, Thyroid Peroxidase FDA UDI
- Generic Name
- Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- ImmunoCAP Specific IgG, Antigen tp, Thyroid Peroxidase FDA UDI
- Model / Reference
- 14-4508-01 FDA UDI
- Description
- ImmunoCAP Specific IgG, Antigen tp, Thyroid Peroxidase FDA UDI
Identifiers
- Catalog Number
- 14-4508-01 FDA UDI
- Primary DI / UDI-DI
- 07333066004013 FDA UDI
- 510(k) Number
- K072661 FDA UDI
- FDA Product Code
- JZO FDA UDI
- GMDN Term
- Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5870 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
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
Category: Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, fluorescent immunoassay
ImmunoCAP Specific IgG, Antigen tp, Thyroid Peroxidase by Phadia GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, fluorescent immunoassay.
Cleared under the same submission
K072661 also covers:
- ImmunoCAP Autoimmunity Specific IgG Sample Diluent — Phadia GmbH
- ImmunoCAP Autoimmunity Specific IgG Sample Diluent — Phadia GmbH
- ImmunoCAP Specific IgG Calibrators — Phadia GmbH
- ImmunoCAP Specific IgG Conjugate — Phadia GmbH
- ImmunoCAP Specific IgG Curve Controls — Phadia GmbH
- ImmunoCAP Specific IgG, Antigen tg, Thyroglobulin — Phadia GmbH
- ImmunoCAP Thyroglobulin IgG Antibodies Control NLH — Phadia GmbH
- ImmunoCAP Thyroid Peroxidase IgG Antibodies Control NLH — 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 0352aab8-8378-4a4d-93bb-cfd48cfa1ae3 37 fields · synced Jun 6, 2026