DEVICE: IH-Card ABO/D(DVI+)+Rev A1,B (07611969952106)
Device Identifier (DI) Information
IH-Card ABO/D(DVI+)+Rev A1,B
813121100
In Commercial Distribution
813121100
Bio-Rad Medical Diagnostics GmbH
813121100
In Commercial Distribution
813121100
Bio-Rad Medical Diagnostics GmbH
Blood Grouping Reagent; Gel card for use with IH-system; Card for ABO/D(DVI+)+ reverse group A1,B typing; 48 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? |
---|---|---|---|---|
45308 | ABO/Rh 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 for a combination of multiple ABO system and Rh group red blood cell antigens, using an agglutination method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
No Product Codes |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Upright position |
Storage Environment Temperature: between 18 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
c630b14e-9a47-47a0-ac59-483bd942f23b
October 19, 2021
3
January 20, 2017
October 19, 2021
3
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 |
---|---|
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