Seraplas V15
Seraplas - 53.428
Device Description
A device intended to be used to create a barrier between the assay container and devices used for aspirating and/or depositing (e.g., pipette), to prevent reagent carryover and spillage, during in vitro diagnostic procedures. It may be used to perforate a sealed single or multichannel assay container and create a working channel for subsequent liquid handling. It is typically made of synthetic polymer materials (e.g., plastic) as a single component, or a strip of multiple liners. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LXG
Device Name: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: Y
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 862.2050
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 04038917081528
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
Device Id: 04038917163842
Device Type: Unit of Use
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