Anti Human Complement C4 (b1e) FITC

FDA UDI

Class II (US FDA UDI)

by Kent Laboratories, Inc.

Identity

Trade Name: Anti Human Complement C4 (b1e) FITC FDA UDI
Generic Name: Complement components C4/C4c IVD, antibody FDA UDI
Device Name: Fluorescein conjugated polyclonal goat antiserum to Human Complement C-4 (b1e) FDA UDI
Model / Reference: 1 FDA UDI
Description: Fluorescein conjugated polyclonal goat antiserum to Human Complement C-4 (b1e) FDA UDI

Identifiers

Catalog Number: 109202 FDA UDI
Primary DI / UDI-DI: B1761092 FDA UDI
FDA Product Code: DBI FDA UDI
GMDN Term: Complement components C4/C4c IVD, antibody FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.5240 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Complement components C4/C4c IVD, antibody

Anti Human Complement C4 (b1e) FITC by Kent Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Complement components C4/C4c IVD, antibody.

Poly Rb A-Hu C4c Complement/FITC — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class II
Human Complement C4 ‘NL’ BINDARID™ Radial Immunodiffusion Kit — The Binding Site Group · Class II
C-4 (b1e) RID plate package — KENT LABORATORIES, INC. · Class I
C-4 (b1e) RID plate kit — KENT LABORATORIES, INC. · Class I
Antiserum to Human C-4 (b1e) — KENT LABORATORIES, INC. · Class II

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: Kent Laboratories, Inc.

Sources (1)

FDA UDI ab1e1f81-d46a-427a-86e0-50897c2c6e9c 36 fields · synced May 30, 2026