DEVICE: BD ProbeTec™ ET CT/GC Amplified DNA Assay Collection Kit (00382902201427)

Device Identifier (DI) Information

BD ProbeTec™ ET CT/GC Amplified DNA Assay Collection Kit
220142
In Commercial Distribution
220142
BECTON, DICKINSON AND COMPANY
00382902201427
GS1

1
122561087 *Terms of Use
BD ProbeTec™ ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Collection Kit for Endocervical Specimens, 100 units Contains: 100 each Sterile rayon-tipped cleaning swabs, CT/GC Diluent tubes
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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
Urogenital specimen transport medium collection kit A collection of sterile devices intended to be used for the collection, preservation, and transport of cellular and/or other material collected from the endocervix, vagina, and male/female urogenital area (e.g., urethra) for investigation by in vitro diagnostic procedures [e.g., nucleic acid technique (NAT), microbiological culture, histopathological cancer screening]. It includes a specimen collection tool(s) [e.g., swab, brush, spatula], and a covered plastic receptacle containing a transport medium (e.g., cell or nucleic acid preservation solution, microbiological medium). This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
LSL DNA-REAGENTS, NEISSERIA
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K984631 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

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

71c5b7a3-b486-4a7a-a499-f6a8edcde58a
July 06, 2018
3
July 12, 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
30382902201428 100 00382902201427 In Commercial Distribution Shelfpack
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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

[?]
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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