Identity
- Trade Name
- NOVEOS IgE Negative Control Pack FDA UDI
- Generic Name
- Allergen-specific immunoglobulin E (IgE) antibody IVD, control FDA UDI
- Model / Reference
- 63155Z FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816879029536 FDA UDI
- 510(k) Number
- K182479 FDA UDI
- FDA Product Code
- DHB FDA UDIJJE FDA UDI
- GMDN Term
- Allergen-specific immunoglobulin E (IgE) antibody IVD, control 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, control
NOVEOS IgE Negative Control Pack 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, control.
- IMMULITE Systems 3gAllergy Specific IgE Positive Control For D1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- IMMULITE Systems 3gAllergy Specific IgE Positive Control for D2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- IMMULITE Systems 3gAllerg Specific IgE Positive Control for M6 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- IMMULITE® Systems neg CONTROL 3gAllergy™ Specific IgE Negative Control — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- IMMULITE® 2000 ALLERGEN SPE Allergen Specific IgE CVM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- NOVEOS IgE Positive Control Pack — HYCOR BIOMEDICAL LLC · Class II
- NOVEOS IgE Negative Control Pack — HYCOR BIOMEDICAL LLC · Class II
- NOVEOS IgE Positive Control Pack — HYCOR BIOMEDICAL LLC · Class II
Cleared under the same submission
K182479 also covers:
- NOVEOS Conjugate IgE — HYCOR BIOMEDICAL LLC
- NOVEOS Conjugate IgE — HYCOR BIOMEDICAL LLC
- NOVEOS Cuvette Wash Pack — HYCOR BIOMEDICAL LLC
- NOVEOS Diluent A Kit — HYCOR BIOMEDICAL LLC
- NOVEOS Diluent A Kit — HYCOR BIOMEDICAL LLC
- NOVEOS Fluo Beads — HYCOR BIOMEDICAL LLC
- NOVEOS Fluo Beads — HYCOR BIOMEDICAL LLC
- NOVEOS House Dust Mite, Dermatophagoides pteronyssinus — HYCOR BIOMEDICAL LLC
- NOVEOS House Dust Mite, Dermatophagoides pteronyssinus — HYCOR BIOMEDICAL LLC
- NOVEOS IgE Calibrator Antibody Pack — HYCOR BIOMEDICAL LLC
- NOVEOS IgE Calibrator Antibody Pack — HYCOR BIOMEDICAL LLC
- NOVEOS IgE Calibrator Set — 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 d963241b-1e6c-47c7-837f-4805559ccfff 35 fields · synced May 30, 2026