Duns Number:004580003
Device Description: The BioCode 2500 Multiplex Detection System is a digital optics imaging system for use wit The BioCode 2500 Multiplex Detection System is a digital optics imaging system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) technology.
Catalog Number
41-A0005
Brand Name
BioCode 2500 Multiplex Detection System
Version/Model Number
1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JJQ
Product Code Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Public Device Record Key
de484c86-b8b1-4451-959b-fd332a5ef95d
Public Version Date
September 24, 2018
Public Version Number
1
DI Record Publish Date
August 22, 2018
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |