Dimension® Heterogenous Immunoassay Module
Dimension® Reaction Vessels - 10445044
Device Description
A device made of disposable materials intended to be placed inside a reusable waste receptacle for the collection and containment of waste, including biologically-contaminated waste products, resulting from in vitro diagnostic procedures. It creates a barrier to contamination, reduces cleaning requirements, and protects the waste receptacle from damage. It is typically made of synthetic polymer materials and should be discarded, with its waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill). This is a single-use device.
Environmental Conditions
- 30.00
- 2.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: JJE
Device Name: Analyzer, Chemistry (Photometric, Discrete), 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: 862.2160
Third Party Flag: N
Medical Specialty: CH
Code: JMG
Device Name: Radioimmunoassay (Two-Site Solid Phase), Ferritin
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 866.5340
Third Party Flag: Y
Medical Specialty: IM
Device IdentifiersDevice Id: 00842768013928
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