Pictus 400 Clinical chemistry analyzer P400-3

GUDID 15999860094224

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.

Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Multiple clinical chemistry analyser IVD, laboratory, automated
Primary Device ID15999860094224
NIH Device Record Keyb43fd163-635e-4203-9186-dedfc327f7bc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePictus 400 Clinical chemistry analyzer
Version Model NumberPictus 400 clinical chemistry analyzer with barcod
Catalog NumberP400-3
Company DUNS427395277
Company NameDiatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com
Phone+1207-450-4228
EmailJohn.Roche@diatron.com

Device Dimensions

Width1050 Millimeter
Width1050 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter
Height630 Millimeter
Depth750 Millimeter
Width1050 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105999860094227 [Primary]
GS115999860094224 [Package]
Contains: 05999860094227
Package: wooden pack [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-12-23
Device Publish Date2018-06-26

On-Brand Devices [Pictus 400 Clinical chemistry analyzer]

05999883586891A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate man
15999860094231A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate man
15999860094224A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate man
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