DEVICE: Control Set for the BD ProbeTec™ CT/GC/TV Qx Amplified DNA Assays (00382904419257)

Device Identifier (DI) Information

Control Set for the BD ProbeTec™ CT/GC/TV Qx Amplified DNA Assays
441925
In Commercial Distribution
441925
BECTON, DICKINSON AND COMPANY
00382904419257
GS1

1
122561087 *Terms of Use
Control Set for the BD ProbeTec™ Chlamydia trachomatis/Neisseria gonorrhoeae/Trichomonas vaginalis (CT/GC/TV) Qx Amplified DNA Assays, 48
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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
Chlamydia trachomatis nucleic acid IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from Chlamydia trachomatis bacteria in a clinical specimen.
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FDA Product Code

[?]
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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 33 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

9c61dd9b-1f23-4f95-8753-60ac55559a25
July 06, 2018
3
July 07, 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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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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