Duns Number:060467826
Device Description: Microbiology Slides Pneumocystis carinii Two-Well Control Slide
Catalog Number
SL75-10
Brand Name
Microbiology Slides
Version/Model Number
SL75-10
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
-
Product Code
LJG
Product Code Name
QUALITY CONTROL SLIDES
Public Device Record Key
34d01ff3-7bc8-4512-a64c-a9268909e639
Public Version Date
May 08, 2020
Public Version Number
1
DI Record Publish Date
April 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 | 1104 |
2 | A medical device with a moderate to high risk that requires special controls. | 24 |