WASH BUFFER
IMMCO DIAGNOSTICS - 2308-1
Device Description
A buffered wash solution intended to be used in combination with other IVDs during the manual processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.
Environmental Conditions
- 8.00
- 2.00
Device Sizes
- for 1 liter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MVM
Device Name: Autoantibodies, Endomysial(Tissue Transglutaminase)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: IM
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: 866.5660
Third Party Flag: Y
Medical Specialty: IM
Code: MSV
Device Name: System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: IM
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: 866.5660
Third Party Flag: Y
Medical Specialty: IM
Code: MST
Device Name: Antibodies, Gliadin
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: IM
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: 866.5750
Third Party Flag: Y
Medical Specialty: IM
Code: MOB
Device Name: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: IM
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: 866.5660
Third Party Flag: Y
Medical Specialty: IM
Code: LRM
Device Name: Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: IM
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: 866.5100
Third Party Flag: Y
Medical Specialty: IM
Code: LLL
Device Name: Extractable Antinuclear Antibody, Antigen And Control
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: IM
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: 866.5100
Third Party Flag: Y
Medical Specialty: IM
Code: LJM
Device Name: Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: IM
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: 866.5100
Third Party Flag: Y
Medical Specialty: IM
Code: DHR
Device Name: System, Test, Rheumatoid Factor
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: IM
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: 866.5775
Third Party Flag: Y
Medical Specialty: IM
Device IdentifiersDevice Id: 00845714004247
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