DEVICE: BD ProbeTec™ (GC) Qx Amplified DNA Assay (00382904411244)
Device Identifier (DI) Information
BD ProbeTec™ (GC) Qx Amplified DNA Assay
441124
In Commercial Distribution
441124
BECTON, DICKINSON AND COMPANY
441124
In Commercial Distribution
441124
BECTON, DICKINSON AND COMPANY
Kit GC Qx Amplified Dna Assay
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
51235 | Neisseria gonorrhoeae 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 Neisseria gonorrhoeae bacteria, the causative agent of gonorrhoea, in a clinical specimen using a nucleic acid technique (NAT).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LSL | DNA-REAGENTS, NEISSERIA |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K081825 | 000 |
K090827 | 000 |
K090971 | 000 |
K091730 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 33 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ab92977d-55c3-47ef-9243-3cebb82715bb
April 05, 2024
3
July 07, 2016
April 05, 2024
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