Duns Number:004321519
Device Description: Sure-Vue Signature Cryptosporidium and Giardia Test Kit
Catalog Number
23200277
Brand Name
Sure-Vue
Version/Model Number
23-200-277
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
MHI
Product Code Name
GIARDIA SPP.
Public Device Record Key
7ea3a34d-2574-46d7-ab0d-2cb283b13ecc
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20613647000308
Quantity per Package
12
Contains DI Package
00613647000304
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 129 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |