AccessGUDID - DEVICE: SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL +) (05055273216509)

GUDID

Device Identifier (DI) Information

Brand Name: SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL +)
Version or Model: SR10352
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SR10352
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273216509
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64864	Multiple-type blood-borne pathogen antibody/antigen IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antibodies to, and antigens from multiple types of blood-borne pathogens in a clinical specimen. Pathogens detected may include (but are not limited to) human immunodeficiency virus 1 and 2 (HIV1 and HIV2), Hepatitis B virus, Hepatitis C virus, human T-cell lymphotrophic virus 1 and/or 2 (HTLV1 and/or HTLV2), and Treponema pallidum.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHQ	Multi-Analyte Controls Unassayed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

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