AccessGUDID - DEVICE: LABScan™ 100 Systems (00812117015699)

GUDID

Device Identifier (DI) Information

Brand Name: LABScan™ 100 Systems
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LABSCNXS2
Company Name: ONE LAMBDA, INC.

Primary DI Number: 00812117015699
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118289289 *Terms of Use

Device Description: A sensitive flow analyzer capable of processing up to 100 bead regions simultaneously and when used with One Lambda’s LABType and LABScreen family of products, the system allows the user to make assignments of HLA antibodies as well as HLA typing with the analysis support of HLA Fusion.

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:	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
NSU	Instrumentation For Clinical Multiplex Test Systems

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: ec196a1d-3493-406e-bee5-f1755abd49a3
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 31, 2016