One Step® Benzodiazepines (BZO300) Home Rapid Test Dipstick
- Primary DI
- 06942598249390
- Brand
- One Step® Benzodiazepines (BZO300) Home Rapid Test Dipstick
- Company
- Hangzhou AllTest Biotech Co., Ltd.
- Model
- 1
- Catalog number
- DBZ-A101H
- Device description
- 5T/kit, EN&.ES, non-CE
- Published
- 2026-10-12
- 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 |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NFV | Test, Benzodiazepine, Over The Counter | Clinical Toxicology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K182738 | 000 |
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K182738 | 000 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2019-03-27 | DKZ |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 06942598249390 | Primary | GS1 | 0 | |
| 86942598249396 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 06942598249390 | 06942598249390 | 6942598249390 |
| 86942598249396 | 86942598249396 |
GMDN Terms#
| Term | Definition |
|---|---|
| Benzodiazepine group 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 benzodiazepine 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
- 543254717
- Device count
- 5
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- 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
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| 16936983131640 | Multi-Drug Rapid Test Panel (Urine) | 1 | DOA-A1124C | 2026-04-16 |
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| 16936983144664 | Discover | DISP-CUP164N$ | 2023-11-30 | |
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