AccessGUDID - DEVICE: Lymphoscreen ABC-60 (07611969952939)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 07611969952939
Issuing Agency: GS1
Commercial Distribution End Date: March 08, 2018
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-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):	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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

FDA Product Code

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Product Code	Product Code Name
MZI	Test,Qualitative,For Hla,Non-Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK980033	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: less than -70 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8399256a-671a-4b2a-b481-fbcb4476b9ce
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 01, 2015