Accuprobe®
Catalogue number ACCUPROBE, N. GONORRHOEAE, listed by Hologic, Inc., United States, under Dna-Reagents, Neisseria. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
2510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
Record
| Listed by | Hologic, Inc., United States |
|---|---|
| FDA product code | LSL |
| Device type | Dna-Reagents, Neisseria |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3390 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-04-15 |
| Record revised | 2024-05-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2021-09-17 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ACCUPROBE, N. GONORRHOEAE | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aptima | Hologic, Inc. | 11 |
| Aptima Combo 2® | Hologic, Inc. | 4 |
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Showing 12 of 53. All products under Dna-Reagents, Neisseria
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231329 | 2024-01-26 |
| K180681 | 2018-06-13 |
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.