Duns Number:790175165
Device Description: immunochromatographic test (IVD) for Human chorionic gonadotropin beta-subunit (beta-HCG)
Catalog Number
07RD7001
Brand Name
QuickProfile™ HCG Test Strip
Version/Model Number
07RD7001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K981770,K981770
Product Code
JHI
Product Code Name
Visual, Pregnancy Hcg, Prescription Use
Public Device Record Key
297a3292-d061-47df-a530-bc4111d4aa05
Public Version Date
September 24, 2018
Public Version Number
3
DI Record Publish Date
November 15, 2017
Package DI Number
M90107RD70011
Quantity per Package
50
Contains DI Package
M90107RD70010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 117 |
| U | Unclassified | 2 |