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Serology Ii Positive Control (serology Ii Control Positive)

EUDAMEDFDA UDI

Class B (EU MDR)

Ref SR10353

by Randox Laboratories Limited

Identity

Trade Name
SEROLOGY II POSITIVE CONTROL (SEROLOGY II CONTROL POSITIVE) EUDAMED
SEROLOGY II POSITIVE CONTROL (SEROLOGY II CONTROL +) FDA UDI
Generic Name
Multiple-type blood-borne pathogen antibody/antigen IVD, control FDA UDI
Device Name
SEROLOGY CONTROL EUDAMED
Serology II Positive Control is intended for use with in vitro assays for determination of antibodies to Hepatitis B Surface Antigen (Anti HBs), IgG antibodies to Hepatitis B Core Antibodies (Anti HBc), antibodies to Hepatitis A (Anti HAV) and antibodies to Hepatitis B Envelope (Anti HBe). Serology II 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 II Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation. FDA UDI
Model / Reference
SR10353 EUDAMEDFDA UDI
Description
Serology II Positive Control is intended for use with in vitro assays for determination of antibodies to Hepatitis B Surface Antigen (Anti HBs), IgG antibodies to Hepatitis B Core Antibodies (Anti HBc), antibodies to Hepatitis A (Anti HAV) and antibodies to Hepatitis B Envelope (Anti HBe). Serology II 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 II Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation. FDA UDI

Identifiers

Catalog Number
SR10353 FDA UDI
Primary DI / UDI-DI
05055273216516 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 Ii Positive Control (serology Ii 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

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Manufacturer

Manufacturer
Randox Laboratories Limited
EUDAMED SRN
XI-MF-000028410

Sources (2)

  • EUDAMED 599e53a2-e274-4a4a-903c-523bb469369a 61 fields · synced Aug 2, 2026
  • FDA UDI ea55ed63-18c5-47ee-821a-5893e36fe959 36 fields · synced May 30, 2026