DEVICE: QuickProfile™ Drugs of Abuse Panel 5 Test (M90107RD7064050)
Device Identifier (DI) Information
QuickProfile™ Drugs of Abuse Panel 5 Test
07RD7064-05
In Commercial Distribution
07RD7064-05
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-05
In Commercial Distribution
07RD7064-05
LUMIQUICK DIAGNOSTICS, INC.
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC/ OPI / THC
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46994 | Multiple drugs of abuse IVD, kit, rapid ICT, clinical |
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DKZ | Enzyme Immunoassay, Amphetamine |
DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
LDJ | Enzyme Immunoassay, Cannabinoids |
DJG | Enzyme Immunoassay, Opiates |
JXM | Enzyme Immunoassay, Benzodiazepine |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 4 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 75 Millimeter |
Device Record Status
fb3d2e96-0be9-416b-ae67-d7e3fc93f30c
June 10, 2022
4
November 15, 2017
June 10, 2022
4
November 15, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
M90107RD7064051 | 25 | M90107RD7064050 | In Commercial Distribution | PACK | |
M90107RD7064052 | 100 | M90107RD7064050 | In Commercial Distribution | PACK |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-408-855-0061
udi@lumiquick.com
udi@lumiquick.com