DEVICE: Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit (B350GSD0113000)
Device Identifier (DI) Information
Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit
GSD01-1300
Not in Commercial Distribution
Gold Standard Diagnostics Corporation
GSD01-1300
Not in Commercial Distribution
Gold Standard Diagnostics Corporation
Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
54809 | Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen, using an enzyme immunoassay (EIA) method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
03912855-e68c-45cd-97c2-7a98c608f07c
August 04, 2021
4
September 27, 2016
August 04, 2021
4
September 27, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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