AccessGUDID - DEVICE: LIFECODES MATCH IT!™ DNA Software v1.2 (10888234400394)

GUDID

Device Identifier (DI) Information

Brand Name: LIFECODES MATCH IT!™ DNA Software v1.2
Version or Model: 888623
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 888623
Company Name: IMMUCOR GTI DIAGNOSTICS, INC.

Primary DI Number: 10888234400394
Issuing Agency: GS1
Commercial Distribution End Date: February 26, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 606034197 *Terms of Use

Device Description: No description.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
60117	DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose or predict donor and recipient tissue compatibility based on one or multiple genetic markers from the major histocompatibility complex (MHC) family of genes, using a nucleic acid technique (NAT). Genetic markers may include HLA-A, HLA-B, HLA-C, DRB1, DRB3, DRB4, DRB5, DQB1, DPB1, MICA and/or C4.	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 [?]
BK150343	0

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 471d67a5-b8f3-45b7-9c02-1679949e959f
Public Version Date: July 28, 2023
Public Version Number: 4
DI Record Publish Date: September 15, 2016