← Back to catalogue

Orange

FDA UDI

Class II (US FDA UDI)

by Hycor Biomedical Llc

Identity

Trade Name
Orange FDA UDI
Generic Name
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI
Device Name
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. FDA UDI
Model / Reference
F033 FDA UDI
Description
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen. FDA UDI

Identifiers

Catalog Number
74247 FDA UDI
Primary DI / UDI-DI
00816879021257 FDA UDI
FDA Product Code
DGC FDA UDI
GMDN Term
Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5510 FDA UDI
Commercial Distribution
Not 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

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Orange by Hycor Biomedical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hycor Biomedical Llc

Sources (1)

  • FDA UDI 4d89b4ba-4f39-403a-9012-4d65a8359836 37 fields · synced Jun 1, 2026