First Sign®
- Primary DI
- 00817763021971
- Brand
- First Sign®
- Company
- HEMOSURE INC.
- Model
- FSCCUP-6664
- Catalog number
- FSCCUP-6664
- Device description
- DOA 6 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure, CLIA Waived AMP/BZO/COC/MOR/OXY/THC
- Published
- 2018-03-12
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- true
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| LDJ | Enzyme Immunoassay, Cannabinoids |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00817763021971 | Primary | GS1 | 0 | |
| 00817763021995 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00817763021971 | 00817763021971 | 817763021971 | 0817763021971 |
| 00817763021995 | 00817763021995 | 817763021995 | 0817763021995 |
GMDN Terms
| Term | Definition |
|---|---|
| Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid | A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 806777541
- Device count
- 25
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00817763022510 | First Sign® | FSCCUP-13124 W/AD7 | FSCCUP-13124 W/AD7 | 2024-10-16 |
| 00817763022824 | First Sign | FSCCUP-21124 | FSCCUP-21124 | 2023-07-05 |
| 00817763022367 | First Sign | FSCDIP1464 | FSCDIP1464 | 2023-05-18 |
| 00817763022572 | FIRST SIGN® | FSCDIP7364 | FSCDIP7364 | 2022-04-21 |
| 00817763022541 | First Sign® | FSCDIP7164 | FSCDIP7164P | 2020-01-08 |
| 00817763022466 | First Sign® | FSCCUP-13124 W/AD | FSCCUP-13124 W/ADP | 2019-10-21 |
| 00817763022442 | FIRST SIGN® | FSCDIP3384 | FSCDIP3384 | 2019-05-14 |
| 00817763022428 | FIRST SIGN® | FSCCUP-3864 | FSCCUP-3864 | 2019-04-29 |
| 00817763020158 | FIRST SIGN® | D0115TC-01 | D0115TC-01 | 2016-09-21 |
| 00817763020165 | FIRST SIGN® | D0115TC-02 | D0115TC-02 | 2016-09-21 |
| 00857338006163 | HEMOSURE® | T1-TC02 | T1-TC02 | 2016-08-24 |
| 00817763022244 | First Sign® | FSCCUP-6664 W/AD7 | 2018-07-23 | |
| 00817763022268 | First Sign® | FSCCUP-20104 W/AD7 | 2018-07-23 | |
| 00817763022220 | First Sign® | FSCCUP-13124 W/AD8 | 2018-06-18 | |
| 00817763022206 | First Sign® | FSCDIP1724 | 2018-05-22 | |
| 00817763022183 | First Sign® | FSCDIP5054 | 2018-05-14 | |
| 00817763022046 | First Sign® | FSCDIPBA-25 | 2018-05-09 | |
| 00817763022060 | First Sign® | FSCDIPED-25 | 2018-05-09 | |
| 00817763022084 | First Sign® | FSCDIPMD-25 | 2018-05-09 | |
| 00817763022107 | First Sign® | FSCDIPMO-25 | 2018-05-09 |
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