SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL +) - Serology I Postive Control is intended for use - RANDOX LABORATORIES LIMITED

Duns Number:227530649

Device Description: Serology I Postive Control is intended for use with in vitro assays for determination of a 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.

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More Product Details

Catalog Number

SR10352

Brand Name

SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL +)

Version/Model Number

SR10352

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

OHQ

Product Code Name

Multi-Analyte Controls Unassayed

Device Record Status

Public Device Record Key

3a363128-e365-4b8a-97d7-b6169aae11b7

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

May 11, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RANDOX LABORATORIES LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 305
2 A medical device with a moderate to high risk that requires special controls. 258