DEVICE: BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit (00382904404765)

Device Identifier (DI) Information

BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit
440476
In Commercial Distribution
440476
BECTON, DICKINSON AND COMPANY
00382904404765
GS1

1
122561087 *Terms of Use
BD ProbeTec™ ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Endocervical Specimen Collection and DRY TRANSPORT Kit Contains: 100 each polyurethane-tipped swab in tubes, rayon-tipped cleaning swabs
CLOSE

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
LSL DNA-REAGENTS, NEISSERIA
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K984631 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

85aabfce-a1c7-4ec6-9562-569fa06e5250
July 06, 2018
3
July 12, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30382904404766 100 00382904404765 In Commercial Distribution Shelfpack
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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