AccessGUDID - DEVICE: SeCore™ CDx HLA A Locus Sequencing Kit (00812117016818)

GUDID

Device Identifier (DI) Information

Brand Name: SeCore™ CDx HLA A Locus Sequencing Kit
Version or Model: SECCDX-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SECCDX-A
Company Name: ONE LAMBDA, INC.

Primary DI Number: 00812117016818
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118289289 *Terms of Use

Device Description: The SeCore CDx HLA Sequencing System is an in-vitro diagnostic intended to be used as a companion diagnostic for the qualitative detection of HLA alleles to aid in the selection of patients to receive specific medicinal products.

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?
56398	HLA class I & II antigen tissue typing IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class I and II antigens in a clinical specimen, using a multiplex method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QUK	Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

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 -30 and -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 76159ba0-7c69-471a-917c-fd0c4221a7d6
Public Version Date: February 07, 2023
Public Version Number: 1
DI Record Publish Date: January 30, 2023