Duns Number:540156544
Device Description: Specimen Gate® Screening Center™ is intended to be used for data management of neonatal sc Specimen Gate® Screening Center™ is intended to be used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Catalog Number
5002-0500
Brand Name
Screening Center
Version/Model Number
5002-0500
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
-
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
-
Product Code
JQP
Product Code Name
Calculator/Data Processing Module, For Clinical Use
Public Device Record Key
26490750-5e84-4a78-be8e-daead5bfbdb2
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 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 | 57 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |
| 3 | A medical device with high risk that requires premarket approval | 2 |