Hologic
Universal General Purpose Reagent - Universal Arm3/Red FRET.
30manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (6), Zhejiang (4). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Takara Biotechnology (Dalian) Co., Ltd. | Dalian | Liaoning | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Biomed Plastics Co. | Taicang | Jiangsu | Contract manufacturer | 29 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Shanghai FLY Medical Devices Co., Ltd. | Minhang District | Shanghai | Manufacturer | 15 |
| Medico Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
Showing 12 of 30. All 30 manufacturers in China registered for General Purpose Reagent
Record
| Listed by | Hologic, Inc., United States |
|---|---|
| FDA product code | PPM |
| Device type | General Purpose Reagent |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-12 |
| Record revised | 2024-06-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to -20 °C |
| Distribution end date | 2021-11-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UNIVERSAL ARM3/RED FRET | In distribution | |
| UNIVERSAL ARM1/RED FRET | In distribution | |
| UNIVERSAL ARM4/RED FRET | Withdrawn | |
| UNIVERSAL ARM6/FAM FRET | Withdrawn | |
| UNIVERSAL ARM4/FAM FRET | Withdrawn | |
| UNIVERSAL ARM6/RED FRET | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diagnostic BioSystems | Diagnostic Biosystems | 62 |
| Epredia | Richard-Allan Scientific LLC | 59 |
| Alpha-Tec Systems | Alpha-Tec Systems, Inc. | 46 |
| Vysis | Abbott Molecular, Inc. | 34 |
| Genemed® | Sakura Finetek U.S.A., Inc. | 33 |
| Edge Biologicals Inc | Edge Biologicals, Inc. | 25 |
| Immunalysis | Immunalysis Corporation | 22 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 22 |
| Bond | Leica Biosystems Newcastle Ltd | 16 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 16 |
| Synchron | Beckman Coulter, Inc. | 13 |
| Immy | Immuno-Mycologics, Inc. | 12 |
Showing 12 of 617. All products under General Purpose Reagent
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.