AccessGUDID - DEVICE: Lymphoscreen ABC-60 (07611969965700)

GUDID

Device Identifier (DI) Information

Brand Name: Lymphoscreen ABC-60
Version or Model: 823300
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Bio-Rad Medical Diagnostics GmbH

Primary DI Number: 07611969965700
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 312576506 *Terms of Use

Device Description: Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependend 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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
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?
56537	HLA class I antibody identification panel IVD, kit, complement-dependent cytotoxicity (CDC)	A collection of reagents and other associated materials intended to be used for the identification in a clinical specimen of one or multiple antibodies to HLA class I antigens, using lymphocyte antigens together with 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 -70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 41922d47-594c-4672-b29b-740d7c393ad6
Public Version Date: January 19, 2024
Public Version Number: 3
DI Record Publish Date: March 08, 2018