Duns Number:834472680
Device Description: Tanner Scientific CLIA waived;Human Chorionic gonadotropin; HCG Combo Cassette,Pregnancy U Tanner Scientific CLIA waived;Human Chorionic gonadotropin; HCG Combo Cassette,Pregnancy Urine/Serum Combo 50BX
Catalog Number
TNR HCGCOMBO
Brand Name
Tanner Scientific®
Version/Model Number
TNR HCGCOMBO
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112101,K112101,K112101
Product Code
JHI
Product Code Name
Visual, Pregnancy Hcg, Prescription Use
Public Device Record Key
52f62a54-7295-49ac-ab54-b50481a11af2
Public Version Date
August 29, 2022
Public Version Number
3
DI Record Publish Date
August 22, 2016
Package DI Number
10850011007171
Quantity per Package
50
Contains DI Package
00850011007174
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |