Jbaids
JBAIDS IVD Influenza A & B Detection Kit
1manufacturer
1catalogue number
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 | BioFire Defense, LLC, United States |
|---|---|
| FDA product code | OCC |
| Device type | Respiratory Virus Panel Nucleic Acid Assay System |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3980 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-07 |
| Record revised | 2020-02-12 (version 4) |
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 |
| Distribution end date | 2017-09-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| JRPD-ASY-0137 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Panther Fusion® | Hologic, Inc. | 4 |
| Prodesse | Hologic, Inc. | 4 |
| Solana | Diagnostic Hybrids, Inc. | 2 |
| Alere™ i Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | 1 |
| Silaris RSV Supplemental Pack | Mesa Biotech, Inc. | 1 |
| Alere i RSV Control Swab Kit | Alere Scarborough, Inc. | 1 |
| ID NOW Influenza A & B 2 Control Swab Kit | Alere Scarborough, Inc. | 1 |
| Xpert Xpress Flu/RSV | Cepheid | 1 |
| ID NOW Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | 1 |
| Simplexa™ Flu A/B & RSV Direct | DiaSorin Molecular LLC | 1 |
| Alere™ i Influenza A & B | Alere Scarborough, Inc. | 1 |
| Respiratory Virus Plus (RV+) Amplification Tray | Nanosphere, Inc. | 1 |
Showing 12 of 39. All products under Respiratory Virus Panel Nucleic Acid Assay System
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.