P780 Clinical Chemistry Analyzer with ISE module

Basic Information

• Brand Name: P780 Clinical Chemistry Analyzer with ISE module
• Primary DI: 05999883586419
• Version / Model: P780 Clinical Chemistry Analyzer with ISE module
• Catalog Number: P780-1
• Company Name: Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag
• Labeler DUNS: 427395277
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-10
• Public Version: 1
• Public Version Date: 2025-07-18
• Public Version Status: New
• Public Device Record Key: 4f12df78-3a23-49a5-bb6a-fe323c5b1227

Device Description

The Pictus 780 is an in vitro diagnostic analyzer made for the continuous and automatic execution of clinical chemistry tests, and for the measurement of electrolytes in human samples, capable of processing up to 600 photometric tests/hour, 780 tests/hour with ISE module.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	862.2160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56676	Multiple clinical chemistry analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05999883586419	GS1
Package	15999883586416	GS1	Wooden box	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	113.5	Centimeter
Depth	77	Centimeter
Height	128	Centimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 18 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 40 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity