Duns Number:072943876
Device Description: A convenience kit consisting of 10 Topcare Ovulation Tests and 1 Topcare Pregnancy Test
Catalog Number
-
Brand Name
Topcare
Version/Model Number
Early Ovulation Test
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
K042280,K981271,K042280,K981271
Product Code
CEP
Product Code Name
Radioimmunoassay, Luteinizing Hormone
Public Device Record Key
11c0a409-2b0d-43c9-ba4a-f704c8797562
Public Version Date
March 15, 2022
Public Version Number
1
DI Record Publish Date
March 07, 2022
Package DI Number
10036800493916
Quantity per Package
24
Contains DI Package
00036800493919
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |