Rapid Response
- Primary DI
- 10722066005511
- Brand
- Rapid Response
- Company
- BTNX Inc
- Model
- D6.6.3-1V
- Device description
- AMP500 COC150 THC50 PCP25 MET500 OPI300
- Published
- 2026-10-09
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| NFV | Test, Benzodiazepine, Over The Counter |
| NFW | Test, Cannabinoid, Over The Counter |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter |
| NGG | Test, Methamphetamine, Over The Counter |
| NGL | Test, Opiates, Over The Counter |
| NGM | Test, Phencyclidine (Pcp), Over The Counter |
| PTG | Test, Methadone, Over The Counter |
| PTH | Test, Barbiturate, Over The Counter |
| QAW | Test, Tricyclic Antidepressants, Over The Counter |
| QBF | Test, Propoxyphene, Over The Counter |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NFV | Test, Benzodiazepine, Over The Counter | Clinical Toxicology | 2 |
| NFW | Test, Cannabinoid, Over The Counter | Clinical Toxicology | 2 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | Clinical Toxicology | 2 |
| NGG | Test, Methamphetamine, Over The Counter | Clinical Toxicology | 2 |
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | 2 |
| NGM | Test, Phencyclidine (Pcp), Over The Counter | Unknown | U |
| PTG | Test, Methadone, Over The Counter | Clinical Toxicology | 2 |
| PTH | Test, Barbiturate, Over The Counter | Clinical Toxicology | 2 |
| QAW | Test, Tricyclic Antidepressants, Over The Counter | Clinical Toxicology | 2 |
| QBF | Test, Propoxyphene, Over The Counter | Clinical Toxicology | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10722066005511 | Primary | GS1 | 0 | |
| 00072206600551 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10722066005511 | 10722066005511 | ||
| 00072206600551 | 00072206600551 | 072206600551 | 0072206600551 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Regulatory Flags#
- DUNS number
- 251005005
- 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 |
|---|---|---|---|---|
| 10722066018979 | Rapid Response | D10.3-1VF | 2026-10-08 | |
| 10722066019013 | Rapid Response | D10.32-1VF | 2026-10-08 | |
| 10722066019020 | Rapid Response | D5.75-1VF | 2026-10-08 | |
| 10722066019037 | Rapid Response | D13.5-1VF | 2026-10-08 | |
| 10722066019044 | Rapid Response | D12.49-1VAF | 2026-10-08 | |
| 10722066018955 | Rapid Response | D5.1-1VF | 2026-10-06 | |
| 10722066018696 | Rapid Response | D7.3-1VF | 2026-09-18 | |
| 10722066018009 | Rapid Response | D13.5-1VA | 2026-07-14 | |
| 10722066015053 | Rapid Response | D12.49-1VAF | 2026-05-15 | |
| 10722066015084 | Rapid Response | D13.5-1VF | 2026-05-15 | |
| 10722066011260 | Rapid Response | D13.5-1VF | 2026-01-19 | |
| 10722066011277 | Rapid Response | D12.49-1VAF | 2026-01-19 | |
| 20722066011267 | Rapid Response | D13.5-1VF | 2026-01-19 | |
| 20722066011274 | Rapid Response | D12.49-1VAF | 2026-01-19 | |
| 10722066011338 | Rapid Response | FOB-9C36 | FOB-9C36 | 2026-01-02 |
| 20722066011335 | Rapid Response | FOB-9C36 | FOB-9C36 | 2026-01-02 |
| 00722066000205 | Rapid Response | HCG-3C50 | HCG-3C50 | 2016-10-25 |
| 00722066000267 | Rapid Response | HCG-3C25 | HCG-3C25 | 2016-10-25 |
| 00722066004548 | Rapid Response | D12.5-1V | 2019-01-21 | |
| 10722066009083 | Rapid Response | D12.49-1VA | 2025-10-03 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06942598249383 | One Step® Buprenorphine (BUP10) Home Rapid Test Dipstick | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-10-12 |
| 06942598249390 | One Step® Benzodiazepines (BZO300) Home Rapid Test Dipstick | Hangzhou AllTest Biotech Co., Ltd. | NFV | 2026-10-12 |
| 06942598249406 | One Step® Methamphetamine (MET500) Home Rapid Test Dipstick | Hangzhou AllTest Biotech Co., Ltd. | NGG | 2026-10-12 |
| 06942598249413 | One Step® Methadone (MTD300) Home Rapid Test Dipstick | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-10-12 |
| 06942598249420 | One Step® Morphine (MOP/OPI2000) Home Rapid Test Dipstick | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-10-12 |
| 06936983113939 | Alltest MDMA500 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGG | 2026-04-21 |
| 06936983113946 | Alltest MET500 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGG | 2026-04-21 |
| 06936983113953 | Alltest MOP300 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983113960 | Alltest MTD300 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983113977 | Alltest MOP2000 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983113984 | Alltest OXY100 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983113991 | Alltest PCP25 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGM | 2026-04-21 |
| 06936983114004 | Alltest TCA1000 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | QAW | 2026-04-21 |
| 06936983114011 | Alltest THC50 Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFW | 2026-04-21 |
| 06936983114035 | Alltest BAR300 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTH | 2026-04-21 |
| 06936983114042 | Alltest BUP10 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983114059 | Alltest BZO300 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFV | 2026-04-21 |
| 06936983114066 | Alltest COC150 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFY | 2026-04-21 |
| 06936983114073 | Alltest EDDP300 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114080 | Alltest MDMA500 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGG | 2026-04-21 |
| 06936983114097 | Alltest MET500 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGG | 2026-04-21 |
| 06936983114103 | Alltest MOP300 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983114110 | Alltest MTD300 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | PTG | 2026-04-21 |
| 06936983114127 | Alltest MOP2000 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983114134 | Alltest OXY100 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGL | 2026-04-21 |
| 06936983114141 | Alltest PCP25 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NGM | 2026-04-21 |
| 06936983114158 | Alltest TCA1000 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | QAW | 2026-04-21 |
| 06936983114165 | Alltest THC50 Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | NFW | 2026-04-21 |
| 06936983114172 | Alltest MDMA500 Rapid Test Dipstick(Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | NGG | 2026-04-21 |
| 06936983114189 | Alltest BZO300 Rapid Test Dipstick(Urine)-CLIA Waived | Hangzhou AllTest Biotech Co., Ltd. | NFV | 2026-04-21 |