AccessGUDID - DEVICE: LIFECODES® QuikScreen® (10888234500094)

GUDID

Device Identifier (DI) Information

Brand Name: LIFECODES® QuikScreen®
Version or Model: QS12G
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: QS12G
Company Name: IMMUCOR GTI DIAGNOSTICS, INC.

Primary DI Number: 10888234500094
Issuing Agency: GS1
Commercial Distribution End Date: December 15, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 606034197 *Terms of Use

Device Description: LIFECODES QuikScreen assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens.

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):	No
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?
56526	HLA class I antibody screening IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used in screening a clinical specimen for one or multiple antibodies to HLA class I antigens, using solid phase antigens together with an enzyme (EIA) immunoassay method.	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 [?]
BK950005	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
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: ffb934eb-f6a8-41ba-afae-c294477d7e7c
Public Version Date: December 16, 2019
Public Version Number: 5
DI Record Publish Date: July 08, 2016