Previ® Color Dual Sample Chambers Slow (TAN)
Catalogue number PREVI® COLOR DUAL SAMPLE CHAMBERS SLOW (, listed by bioMerieux, Inc., United States, under Slide Stainer, Automated. 14 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Shandong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 11 |
| Dakewe(Shenzhen) Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 9 |
| Henan Celnovte Biotechnology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 8 |
| Hangzhou Healthsky Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
| Jiangsu Medomics Medical Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 14. All 14 manufacturers in China registered for Slide Stainer, Automated
Record
| Listed by | bioMerieux, Inc., United States |
|---|---|
| FDA product code | KPA |
| Device type | Slide Stainer, Automated |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-08-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PREVI® COLOR DUAL SAMPLE CHAMBERS SLOW (TAN) | 48 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Shandon Diagnostics Limited | 54 |
| Thermo Fisher | Shandon Diagnostics Limited | 27 |
| Bond | Leica Biosystems Melbourne PTY Ltd | 21 |
| HistoPro® | Rushabh Instruments, LLC | 5 |
| intelliPATH Plus | Biocare Medical, LLC | 4 |
| Alinity | Abbott Laboratories | 4 |
| intelliPATH MAX | Biocare Medical, LLC | 4 |
| Bond | Leica Biosystems Newcastle Ltd | 4 |
| Dako | Agilent Technologies, Inc | 3 |
| Advia Autoslide® Slide Maker Stainer | Siemens Healthcare Diagnostics Inc | 3 |
| Bond-Prime automated stainer | Leica Biosystems Melbourne PTY Ltd | 2 |
| Decloaking Chamber™ NxGen Reconditioned | Biocare Medical, LLC | 2 |
Showing 12 of 153. All products under Slide Stainer, Automated
Recalls
1 of these is 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 | Closed |
|---|---|---|---|---|---|
| 2018-03-23 | Class II | Environmental control | A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMrieux distributor in Guadeloupe to put products in quarantine in Jul | FUCHSIN-A (ref: 29522) 15 eaches; IODINE-B (ref: 29523) 10 e | 2020-06-23 |
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.