BioPlex 2200 Reaction Vessel
BioPlex 2200 - 6602003
Device Description
An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.
Environmental Conditions
- 30.00
- 15.00
Device Sizes
- Total Volume: 1 Milliliter
- 1000 Each
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NSU
Device Name: Instrumentation For Clinical Multiplex Test Systems
Device Class: 2
Physical State: N/A
Definition: Instrumentation for clinical multiplex test systems is a device that is intended to measure and sort multiple signals generated by an assay from a clinical sample. The generated signals from multiple probes or other ligands may be measured by fluorescence, luminescence, or other physical or chemical properties. The device may integrate scanning, reagent handling, hybridization, washing, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. This instrumentation is used with specific assays to comprise an assay test system to measure multiple analytes of a similar chemical nature for de
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: 862.2570
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 00847865002592
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