FIRST SIGN®
- Primary DI
- 00857338006521
- Brand
- FIRST SIGN®
- Company
- HEMOSURE INC.
- Model
- FSCWAM-25
- Catalog number
- FSCWAM-25
- Device description
- DOA Single Test Dip card, 25Pcs/Box; First Sign for HemosureAMP
- Published
- 2016-08-01
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00857338006521 | Primary | GS1 | 0 | |
| 00841824100039 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00857338006521 | 00857338006521 | 857338006521 | 0857338006521 |
| 00841824100039 | 00841824100039 | 841824100039 | 0841824100039 |
GMDN Terms#
| Term | Definition |
|---|---|
| Amphetamine-specific 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 a specific amphetamine 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
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00817763022527 | First Sign® | FSCCUP-13124 W/AD7 | FSCCUP-13124 W/AD7 | 2024-10-16 |
| 00817763022510 | First Sign® | FSCCUP-13124 W/AD7 | FSCCUP-13124 W/AD7 | 2024-10-16 |
| 00817763022831 | First Sign | FSCCUP-21124 | FSCCUP-21124 | 2023-07-05 |
| 00817763022824 | First Sign | FSCCUP-21124 | FSCCUP-21124 | 2023-07-05 |
| 00857338006217 | First Sign | F2-CT25C | F2-CT25C | 2016-05-09 |
| 00857338006224 | First Sign® | F1-CT25U | F1-CT25U | 2016-08-01 |
| 00857338006262 | HEMOSURE | F2-TC01 | F2-TC01 | 2017-06-30 |
| 00857338006330 | First Sign® | F2-CT25C | F2-CT25C | 2016-08-01 |
| 00817763021933 | First Sign® | F1-ST25 | F1-D04 | 2017-11-08 |
| 00817763021964 | Ovultell® | F5-OST20/2 | F5-OST20/2 | 2017-11-13 |
| 00817763022367 | First Sign | FSCDIP1464 | FSCDIP1464 | 2023-05-18 |
| 00857338006576 | FIRST SIGN® | FSCWTH-25 | FSCWTH-25 | 2016-08-01 |
| 00817763020837 | FIRST SIGN® | FSCDIPTH-25 | FSCDIPTH-25 | 2016-10-07 |
| 00817763022589 | FIRST SIGN® | FSCDIP7364 | FSCDIP7364 | 2022-04-21 |
| 00817763022442 | FIRST SIGN® | FSCDIP3384 | FSCDIP3384 | 2019-05-14 |
| 00817763022541 | First Sign® | FSCDIP7164 | FSCDIP7164P | 2020-01-08 |
| 00817763022466 | First Sign® | FSCCUP-13124 W/AD | FSCCUP-13124 W/ADP | 2019-10-21 |
| 00817763022428 | FIRST SIGN® | FSCCUP-3864 | FSCCUP-3864 | 2019-04-29 |
| 00857338006019 | Hemosure | T1-CK30 | T1-CK30 | 2016-05-09 |
| 00857338006026 | HEMOSURE® | T1-CK10 | T1-CK10 | 2016-08-01 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 10722066005290 | Rapid Response Multi-Drug Integrated Split Spec. Cup | BTNX Inc | DKZ | 2023-04-28 |
| 10694644400745 | INCUP | AMERICAN BIO MEDICA CORPORATION | DKZ | 2021-06-24 |
| 10694644300779 | RDS | AMERICAN BIO MEDICA CORPORATION | DKZ | 2021-05-28 |
| 10612479255293 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | DKZ | 2020-06-18 |
| 10612479255323 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | DKZ | 2020-06-18 |
| 10612479258430 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | DKZ | 2020-06-18 |
| 10694644200505 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | DKZ | 2019-10-03 |
| 10694644200499 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | DKZ | 2019-09-28 |
| 10694644400714 | INCUP | AMERICAN BIO MEDICA CORPORATION | DKZ | 2019-03-11 |
| 10694644500407 | RTCII 2nd gen. | AMERICAN BIO MEDICA CORPORATION | DKZ | 2018-12-05 |
| 10694644400707 | INCUP | AMERICAN BIO MEDICA CORPORATION | DKZ | 2018-10-29 |
| 10694644500391 | RTCII 2nd gen. | AMERICAN BIO MEDICA CORPORATION | DKZ | 2018-06-20 |
| 10694644200482 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | DKZ | 2018-05-23 |
| 10722355002573 | Detector Drug Cup | Immunostics Company, Inc | DKZ | 2018-05-21 |
| 10722355002580 | Detector Drug Cup | Immunostics Company, Inc | DKZ | 2018-05-21 |
| 10694644400691 | INCUP | AMERICAN BIO MEDICA CORPORATION | DKZ | 2018-04-20 |
| 10694644200475 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | DKZ | 2018-04-19 |
| 10694644300724 | RDS | AMERICAN BIO MEDICA CORPORATION | DKZ | 2018-04-19 |
| 10694644300700 | RDS | AMERICAN BIO MEDICA CORPORATION | DKZ | 2018-03-23 |
| 10694644300717 | RDS | AMERICAN BIO MEDICA CORPORATION | DKZ | 2018-03-23 |
| 10694644500377 | RTCII 2nd gen. | AMERICAN BIO MEDICA CORPORATION | DKZ | 2018-03-14 |
| 10694644500384 | RTCII 2nd gen. | AMERICAN BIO MEDICA CORPORATION | DKZ | 2018-03-14 |
| 10694644400684 | INCUP | AMERICAN BIO MEDICA CORPORATION | DKZ | 2018-02-16 |
| 10694644300687 | RDS | AMERICAN BIO MEDICA CORPORATION | DKZ | 2018-02-13 |
| 10694644200468 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | DKZ | 2017-10-18 |
| 10694644200451 | RTCII 1st gen. | AMERICAN BIO MEDICA CORPORATION | DKZ | 2017-10-12 |
| 10694644400677 | INCUP | AMERICAN BIO MEDICA CORPORATION | DKZ | 2017-10-10 |
| 10694644500278 | RTCII 2nd gen. | AMERICAN BIO MEDICA CORPORATION | DKZ | 2017-10-06 |
| 10694644500285 | RTCII 2nd gen. | AMERICAN BIO MEDICA CORPORATION | DKZ | 2017-10-06 |
| 10694644500292 | RTCII 2nd gen. | AMERICAN BIO MEDICA CORPORATION | DKZ | 2017-10-06 |