AutoMate1250 – Sorter with Aliquot Module

AutoMate1250 – Sorter with Aliquot Module
Automate 2500 Family - AutoMate 1250

Device Description

An electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data.

Environmental Conditions

Handling Environment Temperature - Percent (%) Relative Humidity

95.00
10.00

Handling Environment Temperature - Degrees Fahrenheit

140.00
-4.00

Special Storage Condition, Specify

Altitude Must not exceed 6,562 ft

Storage Environment Humidity - Percent (%) Relative Humidity

80.00
40.00

Storage Environment Temperature - Degrees Fahrenheit

89.00
64.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: JQP

Device Name: Calculator/Data Processing Module, For Clinical Use

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.2100

Third Party Flag: N

Medical Specialty: CH

Device Identifiers

Device Id: 15099590364106

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A