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Hytec Automated EIA System for Total IgE and Specific IgE

FDA UDI

Class II (US FDA UDI)

by Hycor Biomedical Llc

Identity

Trade Name
Hytec Automated EIA System for Total IgE and Specific IgE FDA UDI
Generic Name
Enzyme immunoassay (EIA) analyser IVD FDA UDI
Model / Reference
288-6002-350 FDA UDI

Identifiers

Primary DI / UDI-DI
00816879022322 FDA UDI
FDA Product Code
DHB FDA UDI
GMDN Term
Enzyme immunoassay (EIA) analyser IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5750 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Hytec Automated EIA System for Total IgE and Specific IgE 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

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Manufacturer

Manufacturer
Hycor Biomedical Llc

Sources (1)

  • FDA UDI 0f1d1b18-c96d-495d-87c9-a1c74b8eeac9 34 fields · synced Jun 1, 2026