DEVICE: IH-Card Anti-D (DVI-) (07611969964758)
Device Identifier (DI) Information
IH-Card Anti-D (DVI-)
813260100
In Commercial Distribution
813260100
Bio-Rad Medical Diagnostics GmbH
813260100
In Commercial Distribution
813260100
Bio-Rad Medical Diagnostics GmbH
Blood Grouping Reagent; Gel card for use with the IH-system; Card for single D (RH1) antigen typing; 12 cards of 6 microtubes
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
52647 | Anti-Rh(D) red blood cell grouping IVD, antibody |
One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for Rh(D) [RH001] red blood cell antigens from the rhesus system, using an agglutination method.
|
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
32b000c7-07e3-4dd1-ba82-d6a54248951a
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 |
---|---|---|---|---|---|
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