Human Complement C4 ‘NL’ BINDARID™ Radial Immunodiffusion Kit

FDA UDI

Class II (US FDA UDI)

by The Binding Site Group

Identity

Trade Name: Human Complement C4 ‘NL’ BINDARID™ Radial Immunodiffusion Kit FDA UDI
Generic Name: Complement components C4/C4c IVD, antibody FDA UDI
Model / Reference: RN025.3 FDA UDI

Identifiers

Primary DI / UDI-DI: 05051700010559 FDA UDI
510(k) Number: K902382 FDA UDI
FDA Product Code: CZW 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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

Human Complement C4 ‘NL’ BINDARID™ Radial Immunodiffusion Kit by The Binding Site Group — Class II — FDA UDI — listed in FDA GUDID

Similar devices

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

Anti Human Complement C4 (b1e) FITC — KENT LABORATORIES, INC. · 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
Poly Rb A-Hu C4c Complement/FITC — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class II

Cleared under the same submission

K902382 also covers:

Human Complement C3 ‘NL’ BINDARID™ Radial Immunodiffusion Kit — The Binding Site Group

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: The Binding Site Group

Sources (1)

FDA UDI 9d6e9b84-fb39-490a-adce-5c679ce39216 35 fields · synced Jun 6, 2026