iScreenTM Oral Fluid Drug Test
- Primary DI
- 06936983197090
- Brand
- iScreenTM Oral Fluid Drug Test
- Company
- Hangzhou AllTest Biotech Co., Ltd.
- Model
- ABTDCTCUBO0102
- Device description
- iScreenTM Oral Fluid Drug Test, EN, 1T
- Published
- 2025-09-26
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| MRS | Test System, Nicotine, Cotinine, Metabolites |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MRS | Test System, Nicotine, Cotinine, Metabolites | Clinical Toxicology | 1 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 06936983197090 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 06936983197090 | 06936983197090 | 6936983197090 |
GMDN Terms#
| Term | Definition |
|---|---|
| Cotinine 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 cotinine (nicotine metabolite) 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 to aid in the differentiation of smokers and non-smokers, or in the investigation of the link between smoking and associated disorders (e.g., cancer, coronary heart disease, stroke). It is not intended to be used for self-testing. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 543254717
- Device count
- 1
- Premarket exempt
- true
- Lot or batch
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 06936983113793 | Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum) | 1 | FHC-A202 | 2026-04-22 |
| 06936983113809 | Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum) | 1 | FHC-A202 | 2026-04-22 |
| 06936983114721 | Alltest BZO300 Home Rapid Test Panel (Urine) | 1 | DBZ-A114H (300ng) | 2026-04-22 |
| 06936983114738 | Alltest BAR300 Home Rapid Test Panel (Urine) | 1 | DBA-A114H (300ng) | 2026-04-22 |
| 06936983114745 | Alltest AMP500 Home Rapid Test Panel (Urine) | 1 | DAM-A114H (500ng) | 2026-04-22 |
| 06936983114752 | Alltest MOP2000 Home Rapid Test Panel(Urine) | 1 | DOP-A114H (2000ng) | 2026-04-22 |
| 06936983114769 | Alltest MOP300 Home Rapid Test Panel (Urine) | 1 | DMO-A114H (300ng) | 2026-04-22 |
| 06936983113939 | Alltest MDMA500 Rapid Test Panel (Urine) | 1 | DMD-A114 (500ng) | 2026-04-21 |
| 06936983113946 | Alltest MET500 Rapid Test Panel (Urine) | 1 | DME-A114 (500ng) | 2026-04-21 |
| 06936983113953 | Alltest MOP300 Rapid Test Panel (Urine) | 1 | DMO-A114 (300ng) | 2026-04-21 |
| 06936983113960 | Alltest MTD300 Rapid Test Panel (Urine) | 1 | DMT-A114 (300ng) | 2026-04-21 |
| 06936983113977 | Alltest MOP2000 Rapid Test Panel (Urine) | 1 | DOP-A114 (2000ng) | 2026-04-21 |
| 06936983113984 | Alltest OXY100 Rapid Test Panel (Urine) | 1 | DOX-A114 (100ng) | 2026-04-21 |
| 06936983113991 | Alltest PCP25 Rapid Test Panel (Urine) | 1 | DPC-A114 (25ng) | 2026-04-21 |
| 06936983114004 | Alltest TCA1000 Rapid Test Panel (Urine) | 1 | DTC-A114 (1000ng) | 2026-04-21 |
| 06936983114011 | Alltest THC50 Rapid Test Panel (Urine) | 1 | DTH-A114 (50ng) | 2026-04-21 |
| 06936983114028 | Alltest AMP500 Rapid Test Dipstick (Urine) | 1 | DAM-A101 (500ng) | 2026-04-21 |
| 06936983114035 | Alltest BAR300 Rapid Test Dipstick (Urine) | 1 | DBA-A101 (300ng) | 2026-04-21 |
| 06936983114042 | Alltest BUP10 Rapid Test Dipstick (Urine) | 1 | DBU-A101 (10ng) | 2026-04-21 |
| 06936983114059 | Alltest BZO300 Rapid Test Dipstick (Urine) | 1 | DBZ-A101 (300ng) | 2026-04-21 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06974246462349 | FIRSTVIEW COT Urine Dip Card Test | Safecare Biotech (Hangzhou) Co., Ltd. | MRS | 2025-07-07 |
| 06970429843417 | co-innovation | Co-Innovation Biotech Co., Ltd | MRS | 2025-05-19 |
| 16970429843414 | co-innovation | Co-Innovation Biotech Co., Ltd | MRS | 2025-05-19 |
| 06936983177252 | FirstCheck Cotinine Oral Fluid Test | Hangzhou AllTest Biotech Co., Ltd. | MRS | 2025-02-14 |
| 00816862026191 | Prime Screen | WONDFO USA CO., LTD. | MRS | 2024-12-24 |
| 10816862026198 | Prime Screen | WONDFO USA CO., LTD. | MRS | 2024-12-24 |
| 06977469280097 | U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold) | Eterbio, Inc. | MRS | 2024-12-18 |
| 06977469280158 | U-Catch Cotinine (COT) Test Dip Card(Colloidal Gold) | Eterbio, Inc. | MRS | 2024-12-18 |
| 00850065976280 | UScreen Oral | Guangzhou Decheng Biotechnology Co., LTD | MRS | 2024-09-27 |
| 00850065976297 | UScreen Oral | Guangzhou Decheng Biotechnology Co., LTD | MRS | 2024-09-27 |
| 00850065976303 | UScreen Oral | Guangzhou Decheng Biotechnology Co., LTD | MRS | 2024-09-27 |
| 00850054867025 | Amazewell | Guangzhou Decheng Biotechnology Co., LTD | MRS | 2024-09-26 |
| 30850054867026 | Amazewell | Guangzhou Decheng Biotechnology Co., LTD | MRS | 2024-09-26 |
| 00810038636443 | Easy@Home Nicotine Urine Test (5 tests one kit) | EASY HEALTHCARE CORPORATION | MRS | 2024-07-17 |
| 20810038636447 | Easy@Home Nicotine Urine Test (5 tests one kit) | EASY HEALTHCARE CORPORATION | MRS | 2024-07-17 |
| 06974246461465 | T Testahead Cotinine(COT) Urine Test Dipcard | Safecare Biotech (Hangzhou) Co., Ltd. | MRS | 2024-06-27 |
| 06974246461472 | T Testahead Cotinine(COT) Urine Test Dipcard | Safecare Biotech (Hangzhou) Co., Ltd. | MRS | 2024-06-27 |
| 06974246461489 | T Testahead Cotinine(COT) Urine Test Dipcard | Safecare Biotech (Hangzhou) Co., Ltd. | MRS | 2024-06-27 |
| 06974246460987 | EXPLORO Highly Sensitive NICOTINE URINE TEST | Safecare Biotech (Hangzhou) Co., Ltd. | MRS | 2023-12-01 |
| 06974246460994 | EXPLORO Highly Sensitive NICOTINE URINE TEST | Safecare Biotech (Hangzhou) Co., Ltd. | MRS | 2023-12-01 |
| 06974246461007 | EXPLORO Highly Sensitive NICOTINE URINE TEST | Safecare Biotech (Hangzhou) Co., Ltd. | MRS | 2023-12-01 |
| 06974246461014 | EXPLORO Highly Sensitive NICOTINE URINE TEST | Safecare Biotech (Hangzhou) Co., Ltd. | MRS | 2023-12-01 |
| 06974246460840 | FIRSTVIEW COT Urine Dip card Test | Safecare Biotech (Hangzhou) Co., Ltd. | MRS | 2023-09-05 |
| 04048474059175 | Cotinine ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | MRS | 2023-09-01 |
| 00810038634654 | Areta Cotinine Test Strip -COT(10 tests one kit) | EASY HEALTHCARE CORPORATION | MRS | 2023-07-19 |
| 00810038634661 | Areta Cotinine Test Strip(25tests one kit) | EASY HEALTHCARE CORPORATION | MRS | 2023-07-19 |
| 30810038634655 | Areta Cotinine Test Strip -COT(10 tests one kit) | EASY HEALTHCARE CORPORATION | MRS | 2023-07-19 |
| 30810038634662 | Areta Cotinine Test Strip(25tests one kit) | EASY HEALTHCARE CORPORATION | MRS | 2023-07-19 |
| 06972428162186 | U-Catch | Shenzhen Bioeasy Biotechnology Co., Ltd | MRS | 2023-03-09 |
| 06974246460727 | Highly Sensitive Nicotine Urine Test | Safecare Biotech (Hangzhou) Co., Ltd. | MRS | 2023-02-16 |