Pictus 400 Clinical chemistry analyzer P400-4

GUDID 15999860094231

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 ID: 15999860094231
• NIH Device Record Key: 238fdb2f-819b-4549-a101-aa295e469e5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pictus 400 Clinical chemistry analyzer
• Version Model Number: Pictus 400 clinical chemistry analyzer with ISE an
• Catalog Number: P400-4
• Company DUNS: 427395277
• Company Name: Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com
• Phone: +1207-450-4228
• Email: John.Roche@diatron.com

Device Dimensions

• Width: 1050 Millimeter
• Width: 1050 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter
• Height: 630 Millimeter
• Depth: 750 Millimeter
• Width: 1050 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05999860094234 [Primary]
GS1	15999860094231 [Package]; Contains: 05999860094234; Package: wooden pack [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101741

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-23
• Device Publish Date: 2018-06-26

On-Brand Devices [Pictus 400 Clinical chemistry analyzer]

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