DEVICE: AutoDELFIA Inhibin A kit (06438147344420)

Device Identifier (DI) Information

AutoDELFIA Inhibin A kit
B064-112
Not in Commercial Distribution
B064-112
Wallac Oy
06438147344420
GS1
April 09, 2025
1
540156544 *Terms of Use
Time-resolved fluoroimmunoassay for the quantitative determination of human Inhibin A.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

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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?
62325 Inhibin A IVD, kit, fluorescent immunoassay
A collection of reagents and other associated materials intended to be used for the quantitative detection of inhibin A in a clinical specimen, using a fluorescent immunoassay method. Inhibin A detection is useful in studies of human reproductive physiology (e.g., as an endocrine marker for monitoring ovarian function).
Active false
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FDA Product Code

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Product Code Product Code Name
NDR Enzyme Immunoassay, Inhibin-A
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

e0f151f6-0b59-43bd-b7d2-6e10f6e4f981
June 12, 2025
3
October 10, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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