Duns Number:878252071
Device Description: DA800TS Microplate Reader is an affordable, high-quality microplate reader for assays in 6 DA800TS Microplate Reader is an affordable, high-quality microplate reader for assays in 6- to 96-well formats. The color touchscreen provides a visual user interface, making programming simple. The onboard software includes “quick read” and custom protocols, with data viewed immediately after measure, followed by export to USB or to the compact printer.
Catalog Number
DAR800TS
Brand Name
Diagnostic Automation
Version/Model Number
DAR800TS
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
JJQ
Product Code Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Public Device Record Key
0122c21a-339f-46d5-ad17-960be771d03d
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
September 16, 2021
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |