Qingdao Hightop Biotech Co., Ltd.
Manufacturer and brand owner in Qingdao, Shandong, China. 14 device types, 1 product catalogued, 3 clearances.
Qingdao Hightop Biotech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Test, Opiates, Over The Counter, Enzyme Immunoassay, Phencyclidine and 12 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2019.
14device types registered with the FDA
1product
3510(k) clearances
Registration
| Registered name | QINGDAO HIGHTOP BIOTECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014223276 |
| FEI number | 3014223276 |
| DUNS | 543270668 |
| Establishment type | Manufacturer |
Location
| City | Qingdao |
|---|---|
| Province | Shandong |
| Address | No.369 Hedong Road, Hi-tech Industrial Development Zone |
| Postal code | 266112 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Enzyme Immunoassay, Phencyclidine | Class U | Hightop® Multi-Drug Urine Test Cup Rx, Hightop® Multi-Drug Urine Test Cup | 2022 | 16 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | Class 2 | VivaGuard Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Midstream, VivaGuard Pregnancy Rapid Test Strip, VivaGuard Pregnancy Rapid Test Midstream | 2019 | 30 |
| Test, Amphetamine, Over The Counter | Class 2 | Hightop® Multi-Drug Urine Test Cup Rx, Hightop® Multi-Drug Urine Test Cup | 2022 | 16 |
| Test, Barbiturate, Over The Counter | Class 2 | Hightop® Multi-Drug Urine Test Cup Rx, Hightop® Multi-Drug Urine Test Cup | 2022 | 16 |
| Test, Benzodiazepine, Over The Counter | Class 2 | Hightop® Multi-Drug Urine Test Cup Rx, Hightop® Multi-Drug Urine Test Cup | 2022 | 16 |
| Test, Cannabinoid, Over The Counter | Class 2 | Hightop® Multi-Drug Urine Test Cup Rx, Hightop® Multi-Drug Urine Test Cup | 2022 | 16 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | Class 2 | Hightop® Multi-Drug Urine Test Cup Rx, Hightop® Multi-Drug Urine Test Cup | 2022 | 16 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | Class 1 | FSH Rapid Test | 2026 | 30 |
| Test, Luteinizing Hormone (Lh), Over The Counter | Class 1 | HIGHTOP (LH) Luteinizing Hormone Rapid Test Strip, HIGHTOP (LH) Luteinizing Hormone Rapid Test Midstream, HIGHTOP (LH) Luteinizing Hormone Rapid Test Cassette | 2019 | 38 |
| Test, Methadone, Over The Counter | Class 2 | Hightop® Multi-Drug Urine Test Cup Rx, Hightop® Multi-Drug Urine Test Cup | 2022 | 17 |
| Test, Methamphetamine, Over The Counter | Class 2 | Hightop® Multi-Drug Urine Test Cup Rx, Hightop® Multi-Drug Urine Test Cup | 2022 | 16 |
| Test, Opiates, Over The Counter | Class 2 | Hightop® Multi-Drug Urine Test Cup Rx, Hightop® Multi-Drug Urine Test Cup, Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel, Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel | 2022 | 18 |
| Test, Propoxyphene, Over The Counter | Class 2 | Hightop® Multi-Drug Urine Test Cup Rx, Hightop® Multi-Drug Urine Test Cup | 2022 | 16 |
| Test, Tricyclic Antidepressants, Over The Counter | Class 2 | Hightop® Multi-Drug Urine Test Cup Rx, Hightop® Multi-Drug Urine Test Cup | 2022 | 16 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| ZiQ | LCX | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K241969 | 2024-08-14 | NGL | Traditional | This company |
| K220685 | 2022-05-05 | NFT | Traditional | This company |
| K192123 | 2019-09-05 | LCX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2009 |
|---|---|
| Employees | 1700+ |
| Factory area | 300,000 m² |
| Main products | Hematology Analyzers, Urinalysis Analyzers & Strips, Biochemistry Analyzers & Reagents, CLIA Analyzers & Reagents, Rapid Tests |
| Certifications | NMPA (617 products), CE (370+), FDA (4), ANVISA (80+) |
| Export markets | Global; 1000+ registered products globally |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.