Duns Number:122561087
Device Description: BD ProbeTec™ ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Ma BD ProbeTec™ ET Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Male Urethral Specimen Collection and DRY TRANSPORT Kit Contains: 100 each rayon-tipped swab
Catalog Number
440461
Brand Name
BD PT ET CT/GC Amplified DNA Assay Male Urethral Collection and Transport Kit
Version/Model Number
440461
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K984631,K984631
Product Code
LSL
Product Code Name
DNA-REAGENTS, NEISSERIA
Public Device Record Key
989169d4-13b2-4e5d-ac94-fc917789d4f7
Public Version Date
January 08, 2021
Public Version Number
5
DI Record Publish Date
July 13, 2016
Package DI Number
30382904404612
Quantity per Package
100
Contains DI Package
00382904404611
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfpack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |