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Pictus 400 Clinical chemistry analyzer

Primary DI
05999883586891
Brand
Pictus 400 Clinical chemistry analyzer
Company
Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
Model
Pictus 400 clinical chemistry analyzer W/out ISE
Catalog number
P400-1
Device description
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.
Published
2018-06-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101741000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101741000DIATRON PICTUS 400Diatron Group2011-01-25CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15999883586898PackageGS11In Commercial Distribution
05999883586891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1599988358689815999883586898
05999883586891059998835868915999883586891

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratory, automatedAn electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with minimal technician involvement and complete automation of all procedural steps.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth750Millimeter
Height630Millimeter
Width1050Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature18 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1207-450-4228John.Roche@diatron.com

Regulatory Flags#

DUNS number
427395277
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05999860094180Pictus 700 clinilcal chemistry analyzerPictus 700 clinilcal chemistry analyzer with ISEP700-32018-06-26
05999883586884Pictus 700 clinilcal chemistry analyzer Pictus 700 clinilcal chemistry analyzer W/out ISE P700-12018-06-26
25999860094153Trigger Solutions Pack226491-TRP2026-01-05
159998600941705x TBS Wash BufferTWB562025-12-11
059998600941735x TBS Wash BufferTWB562025-12-11
05999860094227Pictus 400 Clinical chemistry analyzerPictus 400 clinical chemistry analyzer with barcodP400-32018-06-26
05999860094234Pictus 400 Clinical chemistry analyzerPictus 400 clinical chemistry analyzer with ISE anP400-42018-06-26
05999883586686NA ELECTRODE, ISE MODULENA+ Electrode52012016-10-06
05999883586709CL ELECTRODE, ISE MODULECl- Electrode52032016-10-06
05999883586693K ELECTRODE, ISE MODULEK+ Electrode52022016-10-06
05999883586419P780 Clinical Chemistry Analyzer with ISE moduleP780 Clinical Chemistry Analyzer with ISE moduleP780-12025-07-10
05999883586426P780 Clinical Chemistry AnalyzerP780 Clinical Chemistry AnalyzerP780-22025-07-10
05999883586907Atellica DT Cuvettes (280pcs)Atellica DT Cuvettes (280pcs)113105122025-06-13
15999883586751Atellica DT Solution 1 (S1)Atellica DT Solution 1 (S1)113105072025-04-30
15999883586867Atellica DT Solution 4 (S4)Atellica DT Solution 4 (S4)113105102025-04-30
45999883586752Atellica DT Solution 2 (S2)Atellica DT Solution 2 (S2)113105082025-04-30
05999883586747Atellica DT 250 Analyzer Atellica DT 250113105042025-04-30
15999883586744Atellica DT 250 Analyzer Atellica DT 250113105042025-04-30
25999883586758Atellica DT Solution 1 (S1)Atellica DT Solution 1 (S1)113105072025-04-30
15999883586850Atellica DT Solution 3 (S3)Atellica DT Solution 3 (S3)113105052025-04-30

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