DEVICE: Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™II) (05051700006170)
Device Identifier (DI) Information
Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™II)
LK009.2TB
In Commercial Distribution
THE BINDING SITE GROUP LIMITED
LK009.2TB
In Commercial Distribution
THE BINDING SITE GROUP LIMITED
Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN™II) - Bulk Kit
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? |
---|---|---|---|---|
53787 | Immunoglobulin G subclass (IgG subclass) IVD, kit, nephelometry/turbidimetry |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple immunoglobulin G subclasses (IgG subclasses) in a clinical specimen, using a nephelometry/turbidimetry method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CFN | Method, Nephelometric, Immunoglobulins (G, A, M) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K012292 | 000 |
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
4e10b2cc-253d-43ed-8b71-1cb6f657dfee
September 14, 2018
4
September 24, 2016
September 14, 2018
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
[?]
+4401214569500
info@bindingsite.co.uk
info@bindingsite.co.uk