FDA UDI
In Commercial Distribution
🇺🇸 United States
QuikStrip
DI: 00748349000366
·
Model: 30539
·
SYNTRON BIORESEARCH, INC.
Product Codes
5
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- QuikStrip
- Primary DI
- 00748349000366
- Version / Model
- 30539
- Company Name
- SYNTRON BIORESEARCH, INC.
- Labeler DUNS
- 174517060
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-16
- Public Version
- 5
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6bb77d83-7522-4a2c-a55f-9ab08dc360f3
Device Description
DDS 5 Test COC 300, MET 1000, OPI 300, TCA 1000, THC 50
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | 862.3870 | 2 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | Clinical Toxicology | 862.3910 | 2 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | 862.3650 | 2 |
| DJC | Thin Layer Chromatography, Methamphetamine | Clinical Toxicology | 862.3610 | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | 862.3250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55463 | Drug/toxicology screen adulteration IVD, kit, rapid spectrophotometry, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of drug and/or toxicology screen adulteration of a clinical specimen within a short period, relative to standard laboratory testing procedures, using a rapid spectrophotometry method. This is a rapid test commonly 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 |
|---|---|---|---|---|---|---|
| Package | 20748349000360 | GS1 | 4 | In Commercial Distribution | ||
| Package | 10748349000363 | GS1 | 25 | In Commercial Distribution | ||
| Primary | 00748349000366 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061617 | 000 |