Duns Number:122561087
Device Description: BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens Contains: 100 each ste BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens Contains: 100 each sterile polyester-tipped cleaning swab, sterile polyurethane-tipped collection swab, Q? Swab Diluent tube
Catalog Number
441357
Brand Name
BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens
Version/Model Number
441357
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
1ebd5e4c-5fd8-4a46-bd0e-c09cc6b6aa0b
Public Version Date
July 22, 2021
Public Version Number
5
DI Record Publish Date
May 19, 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 |