Duns Number:781100966
Device Description: Mission Urinalysis Reagent Strips (BLO)
Catalog Number
-
Brand Name
Mission Urinalysis Reagent Strips
Version/Model Number
U031-011
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
-
Product Code
JIO
Product Code Name
BLOOD, OCCULT, COLORIMETRIC, IN URINE
Public Device Record Key
3b9ab4f8-5d80-4b4a-9d57-e67edac59092
Public Version Date
October 07, 2019
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
20682607200065
Quantity per Package
12
Contains DI Package
00682607200061
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 9 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |