DEVICE: 11dhTxB2 Test Kit (11-Dehydro Thromboxane B2) (00855360006274)

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Device Identifier (DI) Information

11dhTxB2 Test Kit (11-Dehydro Thromboxane B2)
12136
12136
CORGENIX MEDICAL CORPORATION
00855360006274
GS1
1
INTENDED USE The 11dhTxB2 Test Kit is an enzyme-linked immunoassay (ELISA) to determine levels of 11-Dehydro Thromboxane B2 (11dhTxB2) in human urine which aids in the qualitative detection of acetylsalicylic acid (ASA) effect in apparently healthy individuals post ingestion. For In Vitro Diagnostic Use. SUMMARY OF THE ASSAY Activated platelets produce Thromboxane A2 (TxA2), a potent vasoconstrictor and inducer of platelet aggregation. TxA2 is generated by Thromboxane synthase from molecules derived from arachidonic acid by cyclooxygenase-1 (COX-1). TxA2 has a short half-life in plasma and is rapidly hydrolyzed to Thromboxane B2 (TxB2). TxB2, in turn, is metabolized to 11-Dehydro Thromboxane B2 (11dhTxB2).The measurement of stable metabolites of TxA2, such as urinary11dhTxB2, is a means of quantitating TxA2 production in vivo and thus a direct way to analyze ASA’s effect post ingestion. PRINCIPLE OF THE TEST The 11dhTxB2 Test Kit measures urinary 11dhTxB2 and is performed as a competitive ELISA. Diluted samples (Reference Solution, controls, and patient urine), purified 11dhTxB2 conjugated to alkaline phosphatase (AP), and purified mouse monoclonal antibody directed to 11dhTxB2 are combined and incubated in microwells coated with a polyclonal anti-mouse antibody. The monoclonal antibody then binds to the polyclonal anti-mouse antibody coated on the microtiter plate. After the removal of unbound complexes by washing, the bound AP-11dhTxB2 conjugate is assayed by the addition of para-nitrophenylphosphate (pNPP) chromogenic substrate. Color develops in the wells at an intensity inversely proportional to the sample urine concentration of 11dhTxB2, and is read at 405nm. Results (pg/mL) are calculated against a reference curve prepared from the Reference Solution provided in the kit. Final results are reported as pg 11dhTxB2 per mg creatinine to normalize results for urine concentration. Refer to product package insert.
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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
Thromboxane IVD, kit, enzyme immunoassay (EIA) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of thromboxane in a clinical specimen, using an enzyme immunoassay (EIA) method. Thromboxane is typically used as a marker of platelet activity, which may be affected by a variety of conditions and treatments (e.g., aspirin intake).
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FDA Product Code

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Product Code Product Code Name
OBW 11-Dehydro Thromboxane B2 Kit, Urinary
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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 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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1-800-729-5661
technicalsupport@corgenix.com
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