Duns Number:545868502
Device Description: NATALIST EARLY Pregnancy Test is a self-testing rapid chromatographic immunoassay for the NATALIST EARLY Pregnancy Test is a self-testing rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. There are 4pcs of midstream in each box.
Catalog Number
RH-HCG-B
Brand Name
NATALIST
Version/Model Number
8363
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
84e1f404-25d1-4707-a98a-293039597da2
Public Version Date
October 19, 2020
Public Version Number
2
DI Record Publish Date
December 25, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |
| U | Unclassified | 1 |