DEVICE: Lumipulse G TP-N Immunoreaction Cartridges Set (04987270235041)
Device Identifier (DI) Information
Lumipulse G TP-N Immunoreaction Cartridges Set
235041
In Commercial Distribution
FUJIREBIO INC.
235041
In Commercial Distribution
FUJIREBIO INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
Yes | |
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Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
59861 | Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Treponema pallidum in a clinical specimen, using a chemiluminescent immunoassay method. The assay is designed to detect infection with Treponema pallidum, the bacteria associated with syphilis.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LIP | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K153145 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: right side up with care; no vibration |
Storage Environment Temperature: between 2 and 10 Degrees Celsius |
Handling Environment Temperature: between 2 and 10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Size Type = Units per kit; Units = 2; Unit of Measure = 2mL |
Device Size Text, specify: Size Type =Tests Per Kit; Size Unit = 42; Unit of Measure = Tests |
Device Record Status
ce567422-3cf8-4bb4-ad7b-de1ca5e86413
July 06, 2018
3
September 16, 2016
July 06, 2018
3
September 16, 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 |
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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
[?]
610-240-3800
customersupport@fdi.com
customersupport@fdi.com