ISOSTAT® Press and Rack for the processing of ISOLATOR Microbial Tubes for adults.
ISOSTAT® Press and Rack - 50C2
Device Description
A device intended to hold a specimen/reagent container (e.g., test tube, tissue specimen petri dish, microplate, cuvette) on board an in vitro diagnostic laboratory instrument or analyser (e.g., PCR machine, spectrophotometric plate reader, biopsy specimen analyser, automated liquid handling station). It may be in the form of a removable tray (excludes immunoassay vehicle trays), holder, shuttle, rack/rack base, slotted case, or other format suitable to be handled and loaded into the parent device by the operator or via an automated process. This is a reusable 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: JKA
Device Name: Tubes, Vials, Systems, Serum Separators, Blood Collection
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: 862.1675
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 00811877010050
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