DEVICE: Lumipulse G FSH-N Immunoreaction Cartridges (04987270235218)
Device Identifier (DI) Information
Lumipulse G FSH-N Immunoreaction Cartridges
235218
Not in Commercial Distribution
FUJIREBIO INC.
235218
Not in Commercial Distribution
FUJIREBIO INC.
No description.
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. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
54187 | Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of follicle stimulating hormone (FSH) in a clinical specimen, using a chemiluminescent immunoassay method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CGJ | Radioimmunoassay, Follicle-Stimulating Hormone |
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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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 |
---|
Device Size Text, specify: Size Type = Tests Per Kit; Size Unit = 42; Unit of Measure = Tests |
Device Record Status
806e369d-56ff-410f-b7d6-769f799ba495
October 10, 2024
5
July 28, 2017
October 10, 2024
5
July 28, 2017
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