DEVICE: GSP Neonatal Biotinidase kit (06438147330911)
Device Identifier (DI) Information
GSP Neonatal Biotinidase kit
3307-001U
In Commercial Distribution
3307-001U
Wallac Oy
3307-001U
In Commercial Distribution
3307-001U
Wallac Oy
For the quantitative determination of human biotinidase activity in dried blood. Note: Kit contains multiple packages.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
59250 | Biotinidase IVD, kit, enzyme fluorescence |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of the enzyme biotinidase in a clinical specimen, using an enzyme fluorescence method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NAK | System,Test,Biotinidase |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K131284 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Storage Environment Temperature: between -30 and -16 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
80d84c78-40b7-4491-8a7a-f7e8f3db9327
July 06, 2018
3
January 12, 2016
July 06, 2018
3
January 12, 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
[?]
No Customer Contact currently defined