FDA UDI
In Commercial Distribution
🇺🇸 United States
QuickProfile™ Drugs of Abuse Test Cup
DI: M90174046II0
·
Model: 74046-II
·
LUMIQUICK DIAGNOSTICS, INC.
Product Codes
9
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- QuickProfile™ Drugs of Abuse Test Cup
- Primary DI
- M90174046II0
- Version / Model
- 74046-II
- Catalog Number
- 74046-II
- Company Name
- LUMIQUICK DIAGNOSTICS, INC.
- Labeler DUNS
- 790175165
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-14
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 577468e7-ec5c-43f7-b121-f4e90feff509
Device Description
Immunoassay for the detection of the following drug substance(s) in human urine: Selection of panel numbers between 1 to 9 from AMP / BAR / BZD / COC / M-AMP / MTD / OPI / PCP / THC
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DJR | Enzyme Immunoassay, Methadone | Clinical Toxicology | 862.3620 | 2 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | 862.3170 | 2 |
| DIS | Enzyme Immunoassay, Barbiturate | Clinical Toxicology | 862.3150 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | 862.3100 | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | 862.3250 | 2 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | 862.3650 | 2 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | 862.3870 | 2 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | U | |
| DJC | Thin Layer Chromatography, Methamphetamine | Clinical Toxicology | 862.3610 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M90174046II0 | HIBCC | ||||
| Package | M90174046II1 | HIBCC | EA | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-408-855-0061
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 74 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 4 – 30 Degrees Celsius