Duns Number:122561087
Device Description: Male Urethral Specimen Collection Kit for the BD ProbeTec™ Chlamydia trachomatis/Neisseria Male Urethral Specimen Collection Kit for the BD ProbeTec™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/GC) Qx Amplified DNA Assays
Catalog Number
441358
Brand Name
Male Urethral Collection Kit for BD ProbeTec™ (CT/GC) Qx Amplified DNA Assays
Version/Model Number
441358
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
K081825,K081825
Product Code
LSL
Product Code Name
DNA-REAGENTS, NEISSERIA
Public Device Record Key
a54a0eb1-bed7-4982-a97f-8642c4ba1be8
Public Version Date
January 08, 2021
Public Version Number
5
DI Record Publish Date
July 07, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |