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ImmunoCAP Thyroglobulin IgG Antibodies Control NLH
FDA UDIClass I (US FDA UDI)
by Phadia GmbH
Identity
- Trade Name
- ImmunoCAP Thyroglobulin IgG Antibodies Control NLH FDA UDI
- Generic Name
- Plasma protein IVD, control FDA UDI
- Device Name
- Contains 2 vials of each IgG antibodies level (N: normal; L: low; H: high) for the ImmunoCAP Thyroglobulin method. FDA UDI
- Model / Reference
- 10-9413-01 FDA UDI
- Description
- Contains 2 vials of each IgG antibodies level (N: normal; L: low; H: high) for the ImmunoCAP Thyroglobulin method. FDA UDI
Identifiers
- Catalog Number
- 10-9413-01 FDA UDI
- Primary DI / UDI-DI
- 07333066019611 FDA UDI
- 510(k) Number
- K072661 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Plasma protein IVD, control 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: Plasma protein IVD, control
ImmunoCAP Thyroglobulin IgG Antibodies Control NLH by Phadia GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 Specific IgG, Antigen tp, Thyroid Peroxidase — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phadia GmbH
Sources (1)
- FDA UDI 0d4ac001-4656-4be7-b2b9-200ef5d3104f 37 fields · synced May 30, 2026