PCRopsis
PCRopsis™ RVD Enhancer (100 mL) is intended to enhance PCR-mediated amplification of gene targets when used in combination with PCRopsis™ Reagent RVD or PCRopsis™ Reagent SRVD.
27manufacturers in China registered for this device type
53catalogue numbers in this listing
7recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (6), Guangdong (4). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Nanning Tecbod Biological Technology Co., Ltd. | Nanning | Guangxi | Contract manufacturer | 51 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Biomed Plastics Co. | Taicang | Jiangsu | Contract manufacturer | 29 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Changsha Renji Medical Equipment Co., Ltd. | Changsha | Hunan | Manufacturer | 15 |
| Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | Nantong | Jiangsu | Manufacturer | 11 |
| Phase Scientific (Shenzhen) Company Limited | Shenzhen | Guangdong | Repacker / relabeller | 8 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
Showing 12 of 27. All 27 manufacturers in China registered for Clinical Sample Concentrator
Record
| Listed by | Entopsis, Inc. |
|---|---|
| FDA product code | JJH |
| Device type | Clinical Sample Concentrator |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2310 |
| Premarket notification | Exempt |
| Record published | 2021-06-08 |
| Record revised | 2022-05-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2024-01-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Lysis Beads | In distribution | ||
| Lysis Beads | In distribution | ||
| Lysis Beads | 250 | In distribution | |
| Support | In distribution | ||
| Lysis Beads | 50 | In distribution | |
| Lysis Beads | In distribution | ||
| Elution Buffer | In distribution | ||
| Pre-Plated Lysis Beads | In distribution | ||
| Reagent RVD with RVD Enhancer | In distribution | ||
| Reagent RVD with RVD Enhancer | In distribution | ||
| Reagent RVD with RVD Enhancer | In distribution | ||
| Support | In distribution | ||
| Support | In distribution | ||
| Support | In distribution | ||
| Lysis Beads | In distribution | ||
| Lysis Beads | In distribution | ||
| Reagent RVD with RVD Enhancer | In distribution | ||
| Elution Buffer | In distribution | ||
| Elution Buffer | In distribution | ||
| BCS Nano | Withdrawn | ||
| Reagent 123 | Withdrawn | ||
| Reagent RVD | Withdrawn | ||
| UrineA | Withdrawn | ||
| Reagent Buccal | Withdrawn | ||
| Reagent Buccal | Withdrawn | ||
| RVD Enhancer | Withdrawn | ||
| Concentrator | 50 | Withdrawn | |
| Reagent SRVD | Withdrawn | ||
| Reagent RVD-E | Withdrawn | ||
| Reagent 123 | Withdrawn | ||
| Activator | Withdrawn | ||
| Reagent 123 | Withdrawn | ||
| Activator | Withdrawn | ||
| Reagent SRVD | Withdrawn | ||
| RVD Enhancer | Withdrawn | ||
| Reagent RVD-RT | Withdrawn | ||
| Concentrator | 250 | Withdrawn | |
| Reagent RVD | Withdrawn | ||
| Reagent SRVD | Withdrawn | ||
| Reagent RVD-RT | Withdrawn | ||
| BCS Nano | Withdrawn | ||
| Reagent RVD | Withdrawn | ||
| Reagent Buccal | Withdrawn | ||
| Elution Buffer | Withdrawn | ||
| BCS Nano | Withdrawn | ||
| Reagent RVD-E | Withdrawn | ||
| Reagent RVD-RT | Withdrawn | ||
| Reagent RVD-WHO | Withdrawn | ||
| Reagent RVD-E | Withdrawn | ||
| Reagent RVD-WHO | Withdrawn | ||
| UrineA | Withdrawn | ||
| Reagent Buccal | Withdrawn | ||
| Reagent 123 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TANBead Nucleic Acid Extraction Kit | Taiwan Advanced Nanotech Inc. | 124 |
| Bioer MagaBio plus Virus DNA /RNA Purification Kit III | Hangzhou Bioer Technology Co., Ltd. | 20 |
| m2000 | Abbott Molecular, Inc. | 19 |
| Allsheng | Hangzhou Allsheng Instruments Co., Ltd. | 13 |
| TANBead Nucleic Acid Extractor | Taiwan Advanced Nanotech Inc. | 12 |
| Bioer MagaBio plus Virus RNA Purification Kit II | Hangzhou Bioer Technology Co., Ltd. | 10 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 9 |
| BioTeke | Bioteke Corporation (Wuxi) Co., Ltd. | 8 |
| Prochem | Vivaproducts, Inc. | 8 |
| Vivafree 500 | Sartorius Stedim Lab Ltd. | 6 |
| Amicon Ultra → 4 | Merck Millipore Ltd. | 6 |
| Vivafree 2 | Sartorius Stedim Lab Ltd. | 6 |
Showing 12 of 268. All products under Clinical Sample Concentrator
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-02-21 | Class II | Under Investigation by firm | Presence of misleading label statements on the product label. | 52 units |
| 2023-02-21 | Class II | Under Investigation by firm | Presence of misleading label statements on the product label. | 6 units |
| 2023-02-21 | Class II | Under Investigation by firm | Presence of misleading label statements on the product label. | 397 units |
| 2023-02-21 | Class II | Under Investigation by firm | Presence of misleading label statements on the product label. | 363 units |
| 2023-02-21 | Class II | Under Investigation by firm | Presence of misleading label statements on the product label. | 97 units |
| 2023-02-21 | Class II | Under Investigation by firm | Presence of misleading label statements on the product label. | 94 units |
| 2023-02-21 | Class II | Under Investigation by firm | Presence of misleading label statements on the product label. | 3 units |
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.