DEVICE: IH-Card RhD(DVI-)+Phenotype (07611969962440)
Device Identifier (DI) Information
IH-Card RhD(DVI-)+Phenotype
813291100
In Commercial Distribution
813291100
Bio-Rad Medical Diagnostics GmbH
813291100
In Commercial Distribution
813291100
Bio-Rad Medical Diagnostics GmbH
Blood Grouping Reagent; Gel card for use with the IH-system; Card for Rhesus phenotyping; 48 cards of 6 microtubes
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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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? |
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45309 | Rhesus (Rh) phenotype (CcDEe)/Kell phenotype multiple blood grouping IVD, kit, agglutination |
A collection of immunoglobulins capable of binding to specific antigenic determinants and intended to be used together in testing a clinical specimen to determine the Rh phenotype (CcDEe) [RH:1,2,3,4,5] and Kell phenotype [KEL:1,2] of red blood cells, using an agglutination method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Upright position |
Storage Environment Temperature: between 18 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4f9ce71f-cd6e-4536-8efd-5b35cb6b4a70
March 29, 2018
2
January 20, 2017
March 29, 2018
2
January 20, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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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