Duns Number:064608573
Device Description: The CLINITEK Status Connector is intended for use with the CLINITEK Status+ analyzer.The c The CLINITEK Status Connector is intended for use with the CLINITEK Status+ analyzer.The connector allows network connectivity and centralized control of all the satellite Point of Care (POC) CLINITEK Status+ analyzerThe connector communicates with remote Hospital and Laboratory Information Systems (HIS/LIS)and interfaces with Electronic Medical Records (EMR).The CLINITEK Status Connector and CLINITEK Status+ analyzer together are the CLINITEK Status Connect system.
Catalog Number
11537761
Brand Name
Clinitek Status Connector
Version/Model Number
11537761
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
K091216
Product Code
CDM
Product Code Name
DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
Public Device Record Key
80ef26a6-cc56-4442-b9df-1f76c69b7c06
Public Version Date
November 19, 2021
Public Version Number
2
DI Record Publish Date
September 30, 2020
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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |