Duns Number:540156544
Device Description: Specimen Gate® Laboratory is a modular laboratory information management system intended f Specimen Gate® Laboratory is a modular laboratory information management system intended for use as a calculator/data processing software for the storage, retrieval, and processing of laboratory data in newborn screening laboratories.
Catalog Number
5002-0180
Brand Name
Specimen Gate Laboratory
Version/Model Number
5002-0180
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
2566c79c-ef58-4ba8-b8b8-f6314ad926cc
Public Version Date
March 27, 2019
Public Version Number
1
DI Record Publish Date
March 19, 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 |