Serology Negative Control (serology Control Negative)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref SR10351

by Randox Laboratories Limited

Identity

Trade Name: SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL NEGATIVE) EUDAMED
SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -) FDA UDI
Generic Name: Multiple-type blood-borne pathogen antibody/antigen IVD, control FDA UDI
Device Name: SEROLOGY CONTROL EUDAMED
Serology Negative Control is intended for use as an unassayed non-reactive quality assurance reagent with in vitro assays detecting antibody to Human Immunodeficiency Virus Type 1/2 (anti-HIV-1/2), antibody to Human T-Lymphotropic Virus Type I/II (anti-HTLV-I/II), Human Immunodeficiency Virus P24 Antigen (HIV P24 Ag), antibody to Hepatitis C Virus (anti-HCV), Immunoglobulin M and total antibodies to Hepatitis B core Antigen (HBc-IgM and anti-HBc Total), Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis B Surface Antigen (anti-HBs), Immunoglobulin M and total antibody to Hepatitis A Virus (HAV-IgM and anti-HAV Total), Hepatitis B Envelope Antigen (HBeAg), antibody to Hepatitis B Envelope Antigen (anti-HBe) and antibodies to Treponema pallidum. Serology Negative Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. Serology Negative Control is helpful in determining the precision of testing systems and in identifying sources of variation. FDA UDI
Model / Reference: SR10351 EUDAMEDFDA UDI
Description: Serology Negative Control is intended for use as an unassayed non-reactive quality assurance reagent with in vitro assays detecting antibody to Human Immunodeficiency Virus Type 1/2 (anti-HIV-1/2), antibody to Human T-Lymphotropic Virus Type I/II (anti-HTLV-I/II), Human Immunodeficiency Virus P24 Antigen (HIV P24 Ag), antibody to Hepatitis C Virus (anti-HCV), Immunoglobulin M and total antibodies to Hepatitis B core Antigen (HBc-IgM and anti-HBc Total), Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis B Surface Antigen (anti-HBs), Immunoglobulin M and total antibody to Hepatitis A Virus (HAV-IgM and anti-HAV Total), Hepatitis B Envelope Antigen (HBeAg), antibody to Hepatitis B Envelope Antigen (anti-HBe) and antibodies to Treponema pallidum. Serology Negative Control is unassayed without target values and is suitable for use on many analysers. These controls must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. Serology Negative Control is helpful in determining the precision of testing systems and in identifying sources of variation. FDA UDI

Identifiers

Catalog Number: SR10351 FDA UDI
Primary DI / UDI-DI: 05055273216493 EUDAMEDFDA UDI
Basic UDI-DI: 50552732BSECONT122LA EUDAMED
FDA Product Code: OHQ FDA UDI
EMDN Code: W0105080807 MULTICONSTITUENT CONTROLS - INF.IMM. EUDAMED
GMDN Term: Multiple-type blood-borne pathogen antibody/antigen IVD, control FDA UDI

Classification

Device Class: Class B EUDAMED
Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
Market of Registration: Northern Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Serology Negative Control (serology Control Negative) by Randox Laboratories Limited — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	50552732BSECONT122LA	Class B	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class B	Pending data

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Manufacturer

Manufacturer: Randox Laboratories Limited
EUDAMED SRN: XI-MF-000028410

Sources (2)

EUDAMED cc5a0ef0-626d-43de-a271-26741e670046 61 fields · synced Jun 18, 2026
FDA UDI 68abc30b-1b32-4f2b-8082-95555b0053ac 36 fields · synced May 29, 2026