Identity
- Trade Name
- Quality Club Specific IgE FDA UDI
- Generic Name
- Plasma protein IVD, control FDA UDI
- Device Name
- Contains one vial each of four different control samples, one vial for each month of a four months period for the ImmunoCAP Specific IgE method. FDA UDI
- Model / Reference
- 10-9298-01 FDA UDI
- Description
- Contains one vial each of four different control samples, one vial for each month of a four months period for the ImmunoCAP Specific IgE method. FDA UDI
Identifiers
- Catalog Number
- 10-9298-01 FDA UDI
- Primary DI / UDI-DI
- 07333066019543 FDA UDI
- FDA Product Code
- OHQ 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
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
Yes
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
Quality Club Specific IgE by Phadia GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Plasma protein IVD, control.
- Alinity — Abbott Laboratories, Inc. · Class I
- Antiserum to Whole Human Serum — KENT LABORATORIES, INC. · Class I
- Alinity — Abbott Laboratories, Inc. · Class I
- K-ASSAY® ASO/RF/CRP Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
- DImension Vista® Protein 1 Control H (high) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- DImension Vista® Cystatin C Control H (high) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- N/T Protein Control SL/L — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
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 eb78e77c-e30d-4b35-9375-56845060aa71 36 fields · synced Jun 8, 2026