Identity
- Trade Name
- NOVEOS Alternaria alternata FDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI
- Model / Reference
- M006 FDA UDI
Identifiers
- Catalog Number
- 63303Z FDA UDI
- Primary DI / UDI-DI
- 00816879029321 FDA UDI
- 510(k) Number
- K220162 FDA UDI
- FDA Product Code
- DHB FDA UDIJJE FDA UDI
- GMDN Term
- Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5750 FDA UDI862.2160 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
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: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
NOVEOS Alternaria alternata by Hycor Biomedical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent.
- IMMULITE®2000 Systems 3gAllergy™ Chicken Feathers — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- ImmunoCAP Allergen c73, Insulin human — Phadia AB · Class B
- BioCLIA Allergy Reagent Kit, I6 — HOB Biotech Group Corp., Ltd. · IVD General
- Allergen Discs Serpula lacrymans — Gold Standard Diagnostics Kassel GmbH · IVD General
- ImmunoCAP Rare Allergen e217, Ferret epithelium — Phadia AB · Class B
- e1 CLIA Microparticles — Autobio Diagnostics Co., Ltd. · Class B
- Sharay Specific IgE (Mix of 22 items) (CLIA) — C-Luminary Biotechnology Co., Ltd. · IVD General
- BioCLIA Allergy Reagent Kit, F88 — HOB Biotech Group Corp., Ltd. · IVD General
Cleared under the same submission
K220162 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hycor Biomedical Llc
Sources (1)
- FDA UDI 7462b4af-6c0b-47ce-b752-287cf8602bb4 36 fields · synced Jun 8, 2026