FDA UDI
In Commercial Distribution
🇺🇸 United States
FIRSTVIEW COT Urine Dip card Test
DI: 06974246460840
·
Model: COT-1014
·
Safecare Biotech (Hangzhou) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FIRSTVIEW COT Urine Dip card Test
- Primary DI
- 06974246460840
- Version / Model
- COT-1014
- Catalog Number
- COT-1014
- Company Name
- Safecare Biotech (Hangzhou) Co., Ltd.
- Labeler DUNS
- 544349634
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-05
- Public Version
- 1
- Public Version Date
- 2023-09-13
- Public Version Status
- New
- Public Device Record Key
- 6c9d56b0-0e9a-4af6-90d2-3f8ee0676ce9
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| MRS | Test System, Nicotine, Cotinine, Metabolites | Clinical Toxicology | 862.3220 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55582 | Cotinine (nicotine metabolite) IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cotinine (nicotine metabolite) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974246460840 | GS1 |