Identity
- Trade Name
- NOVEOS Cow's Milk, Bos taurus FDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI
- Model / Reference
- F002 FDA UDI
Identifiers
- Catalog Number
- 63219Z FDA UDI
- Primary DI / UDI-DI
- 00816879029918 FDA UDI
- 510(k) Number
- K242531 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 Cow's Milk, Bos taurus by Hycor Biomedical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K242531 also covers:
- NOVEOS Bermuda Grass, Cynodon dactylon — HYCOR BIOMEDICAL LLC
- NOVEOS Bermuda Grass, Cynodon dactylon — HYCOR BIOMEDICAL LLC
- NOVEOS Common Ragweed, Ambrosia artemisiifolia — HYCOR BIOMEDICAL LLC
- NOVEOS Common Ragweed, Ambrosia artemisiifolia — HYCOR BIOMEDICAL LLC
- NOVEOS Common Silver Birch, Betula verrucosa — HYCOR BIOMEDICAL LLC
- NOVEOS Common Silver Birch, Betula verrucosa — HYCOR BIOMEDICAL LLC
- NOVEOS Cow's Milk, Bos taurus — HYCOR BIOMEDICAL LLC
- NOVEOS Dog Dander, Canis familiaris — HYCOR BIOMEDICAL LLC
- NOVEOS Dog Dander, Canis familiaris — HYCOR BIOMEDICAL LLC
- NOVEOS Egg White, Gallus gallus — HYCOR BIOMEDICAL LLC
- NOVEOS Egg White, Gallus gallus — HYCOR BIOMEDICAL LLC
- NOVEOS Johnson Grass, Sorghum halepense — HYCOR BIOMEDICAL LLC
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
- Hycor Biomedical Llc
Sources (1)
- FDA UDI 7a94076a-55fb-4f07-b37a-d84f91854285 36 fields · synced May 30, 2026