AccessGUDID - DEVICE: LABScreen™ Single Antigen HLA Class I ExPlex (00812117010199)

GUDID

Device Identifier (DI) Information

Brand Name: LABScreen™ Single Antigen HLA Class I ExPlex
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LS1AEX01
Company Name: ONE LAMBDA, INC.

Primary DI Number: 00812117010199
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118289289 *Terms of Use

Device Description: LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology

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):	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?
56560	HLA class I & II antibody screening IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used in screening for one or multiple antibodies to HLA class I and II antigens in a clinical specimen, using solid phase antigens together with a multiplex 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 [?]
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0184f24b-6f83-4f5e-9d8f-24c9e9e3b894
Public Version Date: June 11, 2020
Public Version Number: 1
DI Record Publish Date: June 03, 2020