Duns Number:082930884
Device Description: Leica Biosystems Ariol DM6000 B for Ariol PL200 Refurbished
Catalog Number
-
Brand Name
Leica Biosystems Ariol DM6000 B for Ariol PL200 Refurbished
Version/Model Number
23MIC1206R
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
NQN
Product Code Name
MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY & PERCENT POSITIVITY
Public Device Record Key
e016b443-8bd7-4592-8923-7c1f4e2e0166
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 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 | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 206 |