DEVICE: DAVID Ovulation Test Midstream (06938444980074)

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Device Identifier (DI) Information

DAVID Ovulation Test Midstream
80074
RH-LH-B
Runbio Biotech Co., Ltd.
06938444980074
GS1
10
The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. This test strip is used to obtain a visual result. It is intended for non-professional, over-the counter (OTC) use.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
Yes
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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
Luteinizing hormone (LH) IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of luteinizing hormone (LH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.
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FDA Product Code

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Product Code Product Code Name
NGE Test, Luteinizing Hormone (Lh), Over The Counter
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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 35.6 and 86 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 08, 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: 06938444980098 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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310-5320009
TestAgents.LLC@gmail.com
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