BioTeke
- Primary DI
- 06974541566049
- Brand
- BioTeke
- Company
- Bioteke Corporation (Wuxi) Co., Ltd.
- Model
- 1 Test/kit
- Catalog number
- ICA2506-14
- Published
- 2026-10-13
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| NFT | Test, Amphetamine, Over The Counter |
| NFV | Test, Benzodiazepine, 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 |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NFT | Test, Amphetamine, Over The Counter | Clinical Toxicology | 2 |
| NFV | Test, Benzodiazepine, 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 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K261409 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 06974541566049 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 06974541566049 | 06974541566049 | 6974541566049 |
Regulatory Flags#
- DUNS number
- 560011452
- Device count
- 1
- 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 |
|---|---|---|---|---|
| 06974541564526 | BioTeke | ST9001-2 | 2025-01-09 | |
| 06974541563031 | BioTeke | ST7001-1 | 2023-02-14 | |
| 06974541563048 | BioTeke | ST7001-2 | 2023-02-14 | |
| 06974541563086 | BioTeke | ST8001-1 | 2023-02-16 | |
| 06974541563109 | BioTeke | ST8001-2 | 2023-02-16 | |
| 06974541563116 | BioTeke | ST8001-2 | 2023-02-16 | |
| 06974541563147 | BioTeke | ST9001-1 | 2023-02-16 | |
| 06974541563154 | BioTeke | ST9001-1 | 2023-02-16 | |
| 06974541564069 | BioTeke | ST9001-2 | 2023-02-08 | |
| 06974541564403 | BioTeke | BTK-H2205 | BTK-H2205 | 2024-05-27 |
| 06974541564397 | BioTeke | BTK-H2201 | BTK-H2201 | 2023-09-12 |
| 06974541564380 | BioTeke | BTK-H2202 | BTK-H2202 | 2023-09-04 |
| 06974541563024 | BioTeke | ST7001-1 | 2023-02-14 | |
| 06974541563055 | BioTeke | ST7001-2 | 2023-02-16 | |
| 06974541563093 | BioTeke | ST8001-1 | 2023-02-16 | |
| 86974541564409 | BioTeke | BTK-H2205 | BTK-H2205 | 2024-05-27 |
| 06974541564373 | bioteke | ST9001-2 | 2023-05-05 | |
| 06974541564335 | BioTeke | ST7001-1 | 2023-03-07 | |
| 06974541564342 | BioTeke | ST7001-1 | 2023-03-07 | |
| 86974541564331 | BioTeke | ST7001-1 | 2023-03-07 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| G754QTUCUP10BU1 | QuikTox Ultra Cup Rapid Drug Test | ADVIN BIOTECH, INC. | PTG | 2026-10-30 |
| G754QTUCUP10BU1 | QuikTox Ultra Cup Rapid Drug Test | ADVIN BIOTECH, INC. | NGG | 2026-10-30 |
| G754QTUCUP10BU1 | QuikTox Ultra Cup Rapid Drug Test | ADVIN BIOTECH, INC. | NFY | 2026-10-30 |
| G754QTUCUP10BU1 | QuikTox Ultra Cup Rapid Drug Test | ADVIN BIOTECH, INC. | NFV | 2026-10-30 |
| G754QTUCUP10BU1 | QuikTox Ultra Cup Rapid Drug Test | ADVIN BIOTECH, INC. | NGL | 2026-10-30 |
| G754QTUCUP10BU1 | QuikTox Ultra Cup Rapid Drug Test | ADVIN BIOTECH, INC. | PTH | 2026-10-30 |
| G754QTUCUP10BU1 | QuikTox Ultra Cup Rapid Drug Test | ADVIN BIOTECH, INC. | NFT | 2026-10-30 |
| G754QTUCUP10BU1 | QuikTox Ultra Cup Rapid Drug Test | ADVIN BIOTECH, INC. | NGM | 2026-10-30 |
| G754QTUCUP5C31 | QuikTox Ultra Cup Rapid Drug Test | ADVIN BIOTECH, INC. | NGL | 2026-10-30 |
| G754QTUCUP5C31 | QuikTox Ultra Cup Rapid Drug Test | ADVIN BIOTECH, INC. | NFT | 2026-10-30 |
| G754QTUCUP5C31 | QuikTox Ultra Cup Rapid Drug Test | ADVIN BIOTECH, INC. | NFY | 2026-10-30 |
| G754QTUCUP5C31 | QuikTox Ultra Cup Rapid Drug Test | ADVIN BIOTECH, INC. | NGG | 2026-10-30 |
| 06978151200287 | Pocguide Multi-Drug Test Panel OTC | Hangzhou Aichek Medical Technology Co., Ltd. | NFT | 2026-10-27 |
| 06978151200287 | Pocguide Multi-Drug Test Panel OTC | Hangzhou Aichek Medical Technology Co., Ltd. | NGL | 2026-10-27 |
| 06978151200287 | Pocguide Multi-Drug Test Panel OTC | Hangzhou Aichek Medical Technology Co., Ltd. | PTH | 2026-10-27 |
| 06978151200287 | Pocguide Multi-Drug Test Panel OTC | Hangzhou Aichek Medical Technology Co., Ltd. | NGG | 2026-10-27 |
| 06978151200287 | Pocguide Multi-Drug Test Panel OTC | Hangzhou Aichek Medical Technology Co., Ltd. | NFV | 2026-10-27 |
| 06978151200287 | Pocguide Multi-Drug Test Panel OTC | Hangzhou Aichek Medical Technology Co., Ltd. | NFY | 2026-10-27 |
| 06978151200287 | Pocguide Multi-Drug Test Panel OTC | Hangzhou Aichek Medical Technology Co., Ltd. | PTG | 2026-10-27 |
| 06978151200287 | Pocguide Multi-Drug Test Panel OTC | Hangzhou Aichek Medical Technology Co., Ltd. | NGM | 2026-10-27 |
| 06978151200287 | Pocguide Multi-Drug Test Panel OTC | Hangzhou Aichek Medical Technology Co., Ltd. | QAW | 2026-10-27 |
| 06978151200294 | Pocguide Multi-Drug Test Cup OTC | Hangzhou Aichek Medical Technology Co., Ltd. | QAW | 2026-10-27 |
| 06978151200294 | Pocguide Multi-Drug Test Cup OTC | Hangzhou Aichek Medical Technology Co., Ltd. | NGM | 2026-10-27 |
| 06978151200294 | Pocguide Multi-Drug Test Cup OTC | Hangzhou Aichek Medical Technology Co., Ltd. | PTG | 2026-10-27 |
| 06978151200294 | Pocguide Multi-Drug Test Cup OTC | Hangzhou Aichek Medical Technology Co., Ltd. | NGG | 2026-10-27 |
| 06978151200294 | Pocguide Multi-Drug Test Cup OTC | Hangzhou Aichek Medical Technology Co., Ltd. | NFY | 2026-10-27 |
| 06978151200294 | Pocguide Multi-Drug Test Cup OTC | Hangzhou Aichek Medical Technology Co., Ltd. | NFV | 2026-10-27 |
| 06978151200294 | Pocguide Multi-Drug Test Cup OTC | Hangzhou Aichek Medical Technology Co., Ltd. | PTH | 2026-10-27 |
| 06978151200294 | Pocguide Multi-Drug Test Cup OTC | Hangzhou Aichek Medical Technology Co., Ltd. | NGL | 2026-10-27 |
| 06978151200294 | Pocguide Multi-Drug Test Cup OTC | Hangzhou Aichek Medical Technology Co., Ltd. | NFT | 2026-10-27 |