Duns Number:066886996
Device Description: One Step Pregnancy (HCG) Urine Test Strip
Catalog Number
CPT01
Brand Name
MAXCHECK
Version/Model Number
CPT01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 12, 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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132085,K132085,K132085
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
962cda23-2550-426f-bbcd-60a80540e71a
Public Version Date
December 14, 2018
Public Version Number
4
DI Record Publish Date
December 19, 2017
Package DI Number
20852359007049
Quantity per Package
25
Contains DI Package
10852359007042
Package Discontinue Date
December 12, 2018
Package Status
Not 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |