DEVICE: Human IgA Subclass NL BINDARID™ Radial Immunodiffusion Kit – Bulk Kit (05051700010375)
Device Identifier (DI) Information
Human IgA Subclass NL BINDARID™ Radial Immunodiffusion Kit – Bulk Kit
RK015
Not in Commercial Distribution
THE BINDING SITE GROUP LIMITED
RK015
Not in Commercial Distribution
THE BINDING SITE GROUP LIMITED
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
61985 | Immunoglobulin A subclass (IgA subclass) IVD, kit, precipitation/immunodiffusion |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple immunoglobulin A subclasses (IgA subclasses) in a clinical specimen, using a precipitation/immunodiffusion method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CZP | Iga, Antigen, Antiserum, Control |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
37279c1f-5e81-472c-848c-ec0adcdc187a
July 21, 2023
4
September 24, 2016
July 21, 2023
4
September 24, 2016
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
[?]
+441214569500
info@bindingsite.co.uk
info@bindingsite.co.uk