DEVICE: ALBAclone Anti-D blend (05060242471452)
Device Identifier (DI) Information
ALBAclone Anti-D blend
Z041U
In Commercial Distribution
ALBA BIOSCIENCE LIMITED
Z041U
In Commercial Distribution
ALBA BIOSCIENCE LIMITED
Blood Grouping Reagent, ALBAclone Anti-D blend (Human/Murine Monoclonal IgM/IgG) for slide and tube techniques.
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
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 |
---|---|
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 |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
528b5e85-ab37-4d9a-b443-063278fef049
March 31, 2022
4
November 28, 2014
March 31, 2022
4
November 28, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05060242471292 | 3 | 05060242471452 | In Commercial Distribution | Carton | |
05060242470929 | 10 | 05060242471452 | In Commercial Distribution | Carton |
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
[?]
+41225458274
olivia.baud@quotientbd.com
olivia.baud@quotientbd.com