Duns Number:064608573
Device Description: For in vitro diagnostic use for quality control of pH/Blood Gas analyzers and ISE analyzer For in vitro diagnostic use for quality control of pH/Blood Gas analyzers and ISE analyzers.
Catalog Number
478942000
Brand Name
RAPIDQC® Plus Level 2
Version/Model Number
10341140
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
K870036,K870036
Product Code
JJS
Product Code Name
CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
Public Device Record Key
c0ae3606-7894-4872-a14a-a94eedd4e3d6
Public Version Date
November 19, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2016
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 |