DEVICE: BD ProbeTec™ ET CT/AC Reagent Pack (00382904404741)
Device Identifier (DI) Information
BD ProbeTec™ ET CT/AC Reagent Pack
440474
In Commercial Distribution
440474
BECTON, DICKINSON AND COMPANY
440474
In Commercial Distribution
440474
BECTON, DICKINSON AND COMPANY
BD ProbeTec™ ET CT/AC Reagent Pack
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, 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 Chlamydia trachomatis bacteria in a clinical specimen, using a nucleic acid technique (NAT). |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LSL | DNA-REAGENTS, NEISSERIA |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K984631 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 33 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
a157876b-908d-441b-a848-c87b72462687
July 06, 2018
3
July 07, 2016
July 06, 2018
3
July 07, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)638-8663
Technical_services@bd.com
Technical_services@bd.com