ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2
BioPlex 2200 - SW4.1_V2
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antinuclear antibodies (ANA) in a clinical specimen, using a multiplex method.
Environmental Conditions
No Data Available
Device Sizes
- 1 Each
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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: LKJ
Device Name: Antinuclear Antibody, 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: 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: MQA
Device Name: Anti-Ribosomal P Antibodies
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: LKO
Device Name: Anti-Rnp 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: 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
Device Identifiers
Device Id: 00847865012331
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
