DEVICE: Lumipulse G B-Amyloid 1-42-N Plasma (04987270235447)

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Device Record History
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Device Identifier (DI) Information
Lumipulse G B-Amyloid 1-42-N Plasma
235447
In Commercial Distribution

FUJIREBIO INC.
04987270235447
GS1

1
710873907 *Terms of Use
Lumipulse G B-Amyloid 1-42-N Plasma IRC
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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?
65902 Tau protein IVD, kit, chemiluminescent immunoassay
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of microtubule-associated tau protein [total tau (t-tau) or phosphorylated tau (p-tau)] in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to aid the diagnosis of neurodegenerative disorders such as Alzheimer's disease.
Active false
65218 Amyloid B component IVD, kit, chemiluminescent immunoassay
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of amyloid B component, also known as amyloid beta or Aß, in a clinical specimen, using a chemiluminescent immunoassay method. It is used to aid the diagnosis of Alzheimer's disease.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
SET Immunoassay Blood Test For Amyloid Pathology Assessment
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K242706 000
No CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 10 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 42 Tests per Kit
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Device Record Status
a06f655f-c61a-4ff8-99be-525a528f4b46
June 19, 2025
4
January 06, 2025
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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.us@fujirebio-us.com
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