AccessGUDID - DEVICE: DQB SSP Kit (07611969953295)

GUDID

Device Identifier (DI) Information

Brand Name: DQB SSP Kit
Version or Model: 826220
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 826220
Company Name: Bio-Rad Medical Diagnostics GmbH

Primary DI Number: 07611969953295
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 312576506 *Terms of Use

Device Description: Kit for 24 determinations of HLA-DQB alleles; For In Vitro Diagnostic Use

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?
56366	HLA class II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple HLA class II antigens in a clinical specimen, using a nucleic acid technique (NAT). It may be used to detect specific HLA gene alleles associated with an inborn/inherited genetic disorder or a predisposition to develop an autoimmune disease (e.g., type 1 diabetes mellitus, Coeliac disease, narcolepsy, Crohn’s disease, inflammatory bowel disease (IBD), psoriasis and rheumatoid arthritis). It may also be used for selecting treatment options for immunotherapy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZI	Test,Qualitative,For Hla,Non-Diagnostic

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: a130fe6c-aa14-431d-b844-e51fefe484b5
Public Version Date: January 19, 2024
Public Version Number: 6
DI Record Publish Date: July 01, 2015