← Back to catalogue

Serology I Positive Control (serology I Control Positive)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref SR10352

by Randox Laboratories Limited

Identity

Trade Name
SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL POSITIVE) EUDAMED
SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL +) FDA UDI
Generic Name
Multiple-type blood-borne pathogen antibody/antigen IVD, control FDA UDI
Device Name
SEROLOGY CONTROL EUDAMED
Serology I Postive Control is intended for use with in vitro assays for determination of antibodies to Human Immunodeficiency Virus Type 1 and 2 (HIV-1/2), antibodies to Human T-Lymphotropic Virus Type 1 and 2 (HTLV-1/2), antibodies to Hepatitis C Virus (HCV), Hepatitis B Surface Antigen (HBsAg), IgG antibodies to Hepatitis B Core Antibodies (HBc) and IgG antibodies to Treponema pallidum. Serology I Positive 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 I Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation. FDA UDI
Model / Reference
SR10352 EUDAMEDFDA UDI
Description
Serology I Postive Control is intended for use with in vitro assays for determination of antibodies to Human Immunodeficiency Virus Type 1 and 2 (HIV-1/2), antibodies to Human T-Lymphotropic Virus Type 1 and 2 (HTLV-1/2), antibodies to Hepatitis C Virus (HCV), Hepatitis B Surface Antigen (HBsAg), IgG antibodies to Hepatitis B Core Antibodies (HBc) and IgG antibodies to Treponema pallidum. Serology I Positive 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 I Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation. FDA UDI

Identifiers

Catalog Number
SR10352 FDA UDI
Primary DI / UDI-DI
05055273216509 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

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Serology I Positive Control (serology I Control Positive) 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Randox Laboratories Limited
EUDAMED SRN
XI-MF-000028410

Sources (2)

  • EUDAMED 4af17e7f-d9c0-4a45-a06c-6a2b5797a849 61 fields · synced Jul 24, 2026
  • FDA UDI 3a363128-e365-4b8a-97d7-b6169aae11b7 36 fields · synced May 30, 2026