Kit for 24 determinations of HLA-DRB alleles; For In Vitro Diagnostic Use

Kit for 24 determinations of HLA
DRB SSP Kit - 826215

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MZI

Device Name: Test, Qualitative, For Hla, Non-Diagnostic

Device Class: U

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: 1

Implant Flag: N

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 07611969953288

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A