Duns Number:255438483
Device Description: BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction Tubes, 24 1 BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction Tubes, 24 1.5 mL Sample Buffer tubes, 25 Septum Caps, 24 Strips Containing, Wash Buffer, Elution Buffer, Neutralization Buffer
Catalog Number
443380
Brand Name
BD MAX™ Enteric Parasite Panel (US/CAN)
Version/Model Number
443380
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 16, 2018
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
K143648
Product Code
OOI
Product Code Name
real time Nucleic acid amplification system
Public Device Record Key
8e1e2c71-c924-4681-a9b3-b949c7f18c1f
Public Version Date
June 09, 2022
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |