DEVICE: BD ProbeTec™ Trichomonas vaginalis (TV) Qx Amplified DNA Assay (00382904419172)

Device Identifier (DI) Information

BD ProbeTec™ Trichomonas vaginalis (TV) Qx Amplified DNA Assay
441917
In Commercial Distribution
441917
BECTON, DICKINSON AND COMPANY
00382904419172
GS1

1
122561087 *Terms of Use
BD ProbeTec™ Trichomonas vaginalis (TV) Qx Amplified DNA Assay, 1152 tests
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Trichomonas vaginalis nucleic acid IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from the parasitic protozoan Trichomonas vaginalis in a clinical specimen, using a nucleic acid technique (NAT).
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FDA Product Code

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Product Code Product Code Name
OUY Trichomonas vaginalis nucleic acid amplification test system
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K130268 000
No 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 33 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

11b734bd-e9da-4846-94fe-dbc78ea505e1
July 06, 2018
3
May 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)638-8663
Technical_services@bd.com
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