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ImmunoCAP Specific IgG Curve Controls
FDA UDIClass I (US FDA UDI)
by Phadia GmbH
Identity
- Trade Name
- ImmunoCAP Specific IgG Curve Controls FDA UDI
- Generic Name
- Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Contains three vials of each Specific IgG Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgG method. FDA UDI
- Model / Reference
- 10-9333-01 FDA UDI
- Description
- Contains three vials of each Specific IgG Curve Control (CC-1, CC-2) for the ImmunoCAP Specific IgG method. FDA UDI
Identifiers
- Catalog Number
- 10-9333-01 FDA UDI
- Primary DI / UDI-DI
- 07333066019581 FDA UDI
- 510(k) Number
- K072661 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Total immunoglobulin G (IgG 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
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 G (IgG total) IVD, kit, enzyme immunoassay (EIA)
ImmunoCAP Specific IgG Curve Controls by Phadia GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA).
- ZYMUTEST HIA IgG — HYPHEN BIOMED · Class II
- ZYMUTEST HIA MonoStrip IgG — HYPHEN BIOMED · Class II
- EliA IgG Conjugate — Phadia GmbH · Class II
- EliA IgG Calibrators — Phadia GmbH · Class II
- EliA IgG Curve Control — Phadia GmbH · Class II
- ImmunoCAP Specific IgG Calibrators — Phadia GmbH · Class I
- ImmunoCAP Specific IgG Conjugate — Phadia GmbH · Class I
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, Antigen tg, Thyroglobulin — Phadia GmbH
- ImmunoCAP Specific IgG, Antigen tp, Thyroid Peroxidase — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Phadia GmbH
Sources (1)
- FDA UDI e44f04cb-964b-4961-939c-45346ab38efc 37 fields · synced May 30, 2026