Duns Number:427395277
Device Description: A discrete photometric chemistry analyzer for clinical use is a device intended to duplica A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.
Catalog Number
P400-4
Brand Name
Pictus 400 Clinical chemistry analyzer
Version/Model Number
Pictus 400 clinical chemistry analyzer with ISE and barcode reader
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
K101741,K101741
Product Code
JJE
Product Code Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Public Device Record Key
238fdb2f-819b-4549-a101-aa295e469e5b
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
June 26, 2018
Package DI Number
15999860094231
Quantity per Package
1
Contains DI Package
05999860094234
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
wooden pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |