FDA UDI
In Commercial Distribution
🇺🇸 United States
First Sign
DI: 00817763022367
·
Model: FSCDIP1464
·
HEMOSURE INC.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- First Sign
- Primary DI
- 00817763022367
- Version / Model
- FSCDIP1464
- Catalog Number
- FSCDIP1464
- Company Name
- HEMOSURE INC.
- Labeler DUNS
- 806777541
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-18
- Public Version
- 1
- Public Version Date
- 2023-05-26
- Public Version Status
- New
- Public Device Record Key
- 4be9bd55-ca6f-4a47-a7a4-b0fee62951f4
Device Description
DOA 6 in 1 Test Dip Card, 25Pcs/Box, First Sign for Hemosure, CLIA Waived, BUP/BZO/COC/MOR/MTD/OXY
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | 862.3170 | 2 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | 862.3250 | 2 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | 862.3650 | 2 |
| DJR | Enzyme Immunoassay, Methadone | Clinical Toxicology | 862.3620 | 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 | 00817763022367 | GS1 |