← Back to catalogue

C4

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
C4 FDA UDI
Generic Name
Complement components C4/C4c IVD, reagent FDA UDI
Device Name
A Complement C4 test system is a device intended for the quantitative in vitro determination of Complement C4 concentration in serum FDA UDI
Model / Reference
CM3846 FDA UDI
Description
A Complement C4 test system is a device intended for the quantitative in vitro determination of Complement C4 concentration in serum FDA UDI

Identifiers

Catalog Number
CM3846 FDA UDI
Primary DI / UDI-DI
05055273201628 FDA UDI
510(k) Number
K000468 FDA UDI
FDA Product Code
DBI FDA UDI
GMDN Term
Complement components C4/C4c IVD, reagent 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

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

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Complement components C4/C4c IVD, reagent

C4 by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K000468 also covers:

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
Randox Laboratories, Ltd.

Sources (1)

  • FDA UDI 9f472be3-49ae-426a-bff2-e0bba61f049b 37 fields · synced Jun 8, 2026