DEVICE: AutoDELFIA Unconjugated Estriol (uE3) kit (06438147119745)

Device Identifier (DI) Information

AutoDELFIA Unconjugated Estriol (uE3) kit
B083-C01
In Commercial Distribution
B083-C01
Wallac Oy
06438147119745
GS1

1
540156544 *Terms of Use
Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3).
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Free estriol (oestriol) IVD, kit, fluorescent immunoassay A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of free estriol (oestriol) in a clinical specimen, using a fluorescent immunoassay method. It is typically measured in maternal blood or urine as a marker of foetal health, gestational age, or fetoplacental distress typically in pregnancies complicated by diabetes, hypertension, or prolonged gestation.
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FDA Product Code

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Product Code Product Code Name
CGI Radioimmunoassay, Estriol
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FDA Premarket Submission

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

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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

7d98a3ce-62b9-4a81-b2e3-8ec5328c5943
March 29, 2018
2
June 01, 2016
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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
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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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