Duns Number:004238200
Device Description: A convenience kit consisting of 50 AccuClear Ovulation Tests + 20 Accuclear Pregnancy Test A convenience kit consisting of 50 AccuClear Ovulation Tests + 20 Accuclear Pregnancy Tests
Catalog Number
-
Brand Name
Accu-Clear
Version/Model Number
Ovulation and Pregnancy Test Combo
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
a7c4e250-97a7-43f3-baf4-1ae259a148dd
Public Version Date
November 19, 2020
Public Version Number
1
DI Record Publish Date
November 11, 2020
Package DI Number
10633472601962
Quantity per Package
60
Contains DI Package
00633472601965
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 241 |
| U | Unclassified | 1 |