DEVICE: AutoDELFIA hAFP Kit (06438147321315)

Device Identifier (DI) Information

AutoDELFIA hAFP Kit
B079-201
In Commercial Distribution
B079-201
Wallac Oy
06438147321315
GS1

1
540156544 *Terms of Use
Time-resolved fluoroimmunoassay for the quantitative determination of human alpha-fetoprotein (hAFP)
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Alpha-fetoprotein (AFP) IVD, kit, fluorescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-fetoprotein (AFP) in a clinical specimen, using a fluorescent immunoassay method.
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FDA Product Code

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Product Code Product Code Name
LOK Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P970037 000
P970037 009
P970037 010
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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

274039f8-e811-4900-85c7-1fb653256ce3
July 06, 2018
3
September 24, 2014
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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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