DEVICE: Lymphoscreen ABC-60 (07611969952939)
Device Identifier (DI) Information
Lymphoscreen ABC-60
823300
Not in Commercial Distribution
823300
Bio-Rad Medical Diagnostics GmbH
823300
Not in Commercial Distribution
823300
Bio-Rad Medical Diagnostics GmbH
Human lymphocytes for 6 detections of human HLA-ABC antibodies in the complement-dependent microlymphocytotoxicity test
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 [?] |
---|---|
BK980033 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: less than -70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8399256a-671a-4b2a-b481-fbcb4476b9ce
July 06, 2018
3
July 01, 2015
July 06, 2018
3
July 01, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-224-6723
techsupport.bmd@bio-rad.com
techsupport.bmd@bio-rad.com