FIRST SIGN®
- Primary DI
- 00817763020752
- Brand
- FIRST SIGN®
- Company
- HEMOSURE INC.
- Model
- FSCDIP874
- Catalog number
- FSCDIP874
- Device description
- DOA 7 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/BZO/COC/mAMP/OPI/PCP/THC
- Published
- 2016-10-07
- Public version status
- Update
- 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 |
|---|---|
| JXM | Enzyme Immunoassay, Benzodiazepine |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00817763020752 | Primary | GS1 | 0 | |
| 00817763021445 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00817763020752 | 00817763020752 | 817763020752 | 0817763020752 |
| 00817763021445 | 00817763021445 | 817763021445 | 0817763021445 |
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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|---|---|---|---|---|
| 10810173655993 | Healgen | Healgen Scientific Limited Liability Company | JXM | 2026-03-11 |
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| 10810173655658 | Healgen | Healgen Scientific Limited Liability Company | JXM | 2026-02-04 |
| 00810173655101 | Healgen | Healgen Scientific Limited Liability Company | JXM | 2026-01-31 |
| 10810173655603 | Healgen | Healgen Scientific Limited Liability Company | JXM | 2026-01-30 |
| 10810173655641 | Healgen | Healgen Scientific Limited Liability Company | JXM | 2026-01-30 |
| 00810173654821 | Healgen | Healgen Scientific Limited Liability Company | JXM | 2026-01-08 |
| 00810173654838 | Healgen | Healgen Scientific Limited Liability Company | JXM | 2026-01-08 |
| 00850054026989 | QMedix™ | Diagnostic Automation, Inc. | JXM | 2025-12-23 |
| 00850054026996 | QMedix™ | Diagnostic Automation, Inc. | JXM | 2025-12-23 |
| 10810173654002 | Healgen | Healgen Scientific Limited Liability Company | JXM | 2025-12-19 |
| 10810173654149 | Healgen | Healgen Scientific Limited Liability Company | JXM | 2025-12-19 |
| 10810173654644 | Healgen | Healgen Scientific Limited Liability Company | JXM | 2025-12-19 |
| 00850013035830 | Identify®Diagnostics Drug Test Cups | MEDICAL DISTRIBUTION GROUP INC | JXM | 2025-12-04 |
| 00817038022252 | 10 Panel Drug Test Cup | UCP BIOSCIENCES, INC. | JXM | 2025-03-24 |
| 10815845024305 | SureStep™ Urine Test Drug Screen Strip | ALERE SAN DIEGO, INC. | JXM | 2024-12-17 |
| 00841824105409 | N/A | W.H.P.M. INC. | JXM | 2024-06-14 |
| 10810124273023 | SureStepTM Urine Test Drug Screen Strip, Benzodiazepines (BZO 300) | ALERE SAN DIEGO, INC. | JXM | 2023-12-15 |
| 10810124273283 | SureStep™ Urine Test Drug Screen Cassette, Benzodiazepines (BZO 300) | ALERE SAN DIEGO, INC. | JXM | 2023-12-15 |
| 10810124273726 | CERTUM BZO One Step Benzodiazepines Test Strip | ALERE SAN DIEGO, INC. | JXM | 2023-12-15 |
| 00817763022367 | First Sign | HEMOSURE INC. | JXM | 2023-05-18 |
| 04015630999347 | ONLINE DAT Benzodiazepines II | Roche Diagnostics GmbH | JXM | 2023-05-11 |
| 07613336121054 | ONLINE DAT Benzodiazepines II | Roche Diagnostics GmbH | JXM | 2023-05-11 |
| 00850041101750 | Onsite DrugScreen | Medical Disposables Corp | JXM | 2023-04-24 |
| 00850041101781 | Onsite DrugScreen | Medical Disposables Corp | JXM | 2023-04-24 |
| 00850041101798 | Onsite DrugScreen | Medical Disposables Corp | JXM | 2023-04-24 |
| 10817405022936 | iCup™ | Instant Technologies, Inc. | JXM | 2023-02-09 |
| 30817405022282 | iScreen™ | Instant Technologies, Inc. | JXM | 2023-02-07 |
| 30817405022565 | iCassette™ | Instant Technologies, Inc. | JXM | 2023-02-07 |
| B77830573OD0 | Origin Instant Dip Drug Test | ORIGIN DIAGNOSTICS LLC | JXM | 2022-12-07 |