D3 Fastpoint
D3 Fastpoint Resp Virus ID KIT
2manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 21 |
Record
| Listed by | Diagnostic Hybrids, Inc., United States |
|---|---|
| FDA product code | GQS |
| Device type | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3400 |
| Record published | 2016-09-15 |
| Record revised | 2025-05-23 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Respiratory Virus ID Kit | In distribution | |
| 01-120000.B1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imagen Parainfluenza Virus Types 1, 2 and 3 | Oxoid, Ltd. | 1 |
| Imagen Parainfluenza Virus Types 1, 2, 3 | Oxoid, Ltd. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K093415 | 2009-12-23 |
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.