Syva® RapidTest d.a.u.® 5 mAMP / OPI / COC / THC / PCP
Syva® RapidTest d.a.u.® 5 - 10445360
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
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: DIO
Device Name: Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: TX
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: 862.3250
Third Party Flag: Y
Medical Specialty: TX
Code: DNI
Device Name: Liquid Chromatography, Amphetamine
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: TX
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: 862.3100
Third Party Flag: Y
Medical Specialty: TX
Code: LCM
Device Name: Enzyme Immunoassay, Phencyclidine
Device Class: U
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: TX
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: 1
Implant Flag: N
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 00842768001314
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: 00630414013947
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