FIRST SIGN®
- Primary DI
- 00817763022428
- Brand
- FIRST SIGN®
- Company
- HEMOSURE INC.
- Model
- FSCCUP-3864
- Catalog number
- FSCCUP-3864
- Device description
- DOA 6 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure, CLIA Waived, AMP/BZO/COC/OPI/OXY/THC
- Published
- 2019-04-29
- 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 |
|---|---|
| JXN | Enzyme Immunoassay, Propoxyphene |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| JXN | Enzyme Immunoassay, Propoxyphene | Clinical Toxicology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00817763022428 | Primary | GS1 | 0 | |
| 00817763022411 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00817763022428 | 00817763022428 | 817763022428 | 0817763022428 |
| 00817763022411 | 00817763022411 | 817763022411 | 0817763022411 |
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
- true
- 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 |
| 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 | |
| 00817763022121 | First Sign® | FSCDIPMT-25 | 2018-05-09 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 10810124273672 | SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup | ALERE SAN DIEGO, INC. | JXN | 2024-09-17 |
| 00841824105034 | N/A | W.H.P.M. INC. | JXN | 2023-02-14 |
| 00869419000236 | Express ResultsTM | Quest Diagnostics | JXN | 2022-03-28 |
| 00841824104853 | NA | W.H.P.M. INC. | JXN | 2021-10-12 |
| 10694644450740 | INCUP | AMERICAN BIO MEDICA CORPORATION | JXN | 2021-06-24 |
| 00816036027160 | STATCUP® | MICRO DISTRIBUTING, L.C | JXN | 2021-01-14 |
| 00811727017918 | Pointe Propoxyphene (PPX) Reagent Set | POINTE SCIENTIFIC, INC. | JXN | 2020-09-25 |
| 00811727017925 | Pointe Propoxyphene (PPX) Reagent Set | POINTE SCIENTIFIC, INC. | JXN | 2020-09-25 |
| 10694644150459 | Rapid TOX | AMERICAN BIO MEDICA CORPORATION | JXN | 2020-05-29 |
| 07613336166116 | Propoxyphene Plus | Roche Diagnostics GmbH | JXN | 2020-03-05 |
| 00841824101920 | ECO® II Cup | W.H.P.M. INC. | JXN | 2020-01-17 |
| 00380740165307 | Alinity | ABBOTT LABORATORIES | JXN | 2019-10-10 |
| 10694644200505 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | JXN | 2019-10-03 |
| 00850798007787 | CSI | TRANSMED CO, LLC | JXN | 2019-10-01 |
| 20816490022941 | Healgen | Healgen Scientific Limited Liability Company | JXN | 2019-07-31 |
| 20816490022866 | Healgen | Healgen Scientific Limited Liability Company | JXN | 2019-07-29 |
| 00841824104334 | ECO® II Cup | W.H.P.M. INC. | JXN | 2019-07-10 |
| 00816036026569 | STATCUP® | MICRO DISTRIBUTING, L.C | JXN | 2019-07-02 |
| 00812203030148 | Generic | CHEMTRON BIOTECH INC | JXN | 2019-04-29 |
| 20850721007888 | Identify Diagnostics USA | MEDICAL DISTRIBUTION GROUP INC | JXN | 2019-04-18 |
| 00817815020259 | CRL STAT Cup | CLINICAL REFERENCE LABORATORY, INC. | JXN | 2019-03-18 |
| 00858886006322 | Noble 1 Step Cup | NOBLE MEDICAL INC | JXN | 2019-01-24 |
| 00855944007383 | Easy@Home 9 Panel Instant Urine Drug Test (2 test kit) | EASY HEALTHCARE CORPORATION | JXN | 2018-06-26 |
| 20816490021883 | Healgen | Healgen Scientific Limited Liability Company | JXN | 2018-04-24 |
| 00851950008154 | Arvolife | Clinical Guard | JXN | 2018-03-26 |
| 00630414595948 | Atellica CH Ppx | Siemens Healthcare Diagnostics Inc. | JXN | 2017-12-22 |
| 00816036025623 | STATDIP® | MICRO DISTRIBUTING, L.C | JXN | 2017-12-04 |
| 00816036025920 | STATDIP® | MICRO DISTRIBUTING, L.C | JXN | 2017-12-04 |
| 20612479215393 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | JXN | 2017-08-02 |
| 20612479215409 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | JXN | 2017-08-02 |