AccessGUDID - DEVICE: Lymphotype HLA-ABC 120 (07611969952779)

GUDID

Device Identifier (DI) Information

Brand Name: Lymphotype HLA-ABC 120
Version or Model: 823030
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 823030
Company Name: Bio-Rad Medical Diagnostics GmbH

Primary DI Number: 07611969952779
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 312576506 *Terms of Use

Device Description: for 3 detections of human HLA-ABC antigens in the complement-dependent microlymphocytotoxicity test

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):	Yes
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?
56321	HLA class I antigen tissue typing IVD, kit, complement-dependent cytotoxicity (CDC)	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 antigens in a clinical specimen, using a complement-dependent cytotoxicity (CDC) 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
Storage Environment Temperature: less than -20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f7299c03-90a2-45d6-9e23-6b10b8cf16d4
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 01, 2015