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.
04987270235041
GS1

1
710873907 *Terms of Use
No description.
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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. 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K153145 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
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
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Clinically Relevant Size

[?]
Size Type Text
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
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Device Record Status

ce567422-3cf8-4bb4-ad7b-de1ca5e86413
July 06, 2018
3
September 16, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
610-240-3800
customersupport@fdi.com
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