Remel Inc- Buffered Peptone Water
Buffered Peptone Water
7manufacturers in China registered for this device type
1catalogue number
6recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Jiangxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Zhejiang Runlab Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| Rusun Medical Co., Ltd. | Yichun | Jiangxi | Manufacturer | 37 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
Record
| Listed by | Remel, Inc., United States |
|---|---|
| FDA product code | LIB |
| Device type | Device, General Purpose, Microbiology, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2660 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-08-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R112133 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel | Remel, Inc. | 45 |
| Caplugs/Evergreen | Caplugs, Inc. | 28 |
| Device, General Purpose, Microbiology, Diagnostic | Scientific Device Laboratory, Inc. | 21 |
| Globe Scientific | Globe Scientific, LLC | 20 |
| Medline | Medline Industries, Inc. | 15 |
| Parasite Suspensions | Microbiologics, Inc. | 12 |
| Inoculating Loop | Zhejiang Runlab Technology Co., Ltd. | 4 |
| Planet-Safe® | Diversified Biotech, Inc. | 4 |
| Device, General Purpose, Microbiology, Diagnostic | Hardy Diagnostics | 4 |
| Inoculating Loop Typenex | Zhejiang Runlab Technology Co., Ltd. | 4 |
| MicroScan | Beckman Coulter, Inc. | 3 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 2 |
Showing 12 of 64. All products under Device, General Purpose, Microbiology, Diagnostic
Recalls
4 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 | Closed |
|---|---|---|---|---|---|
| 2014-10-23 | Class II | Other | A reagent within the test may return false negative results. | 59/50 test boxes | 2015-01-22 |
| 2014-10-23 | Class II | Other | A reagent within the test may return false negative results. | 2/50 test boxes | 2015-01-22 |
| 2014-03-17 | Class II | Under Investigation by firm | A reagent contained within the product may return false negative results. | 2/50-test boxes | 2014-12-11 |
| 2014-03-17 | Class II | Under Investigation by firm | A reagent contained within the product may return false negative results. | 72/50-test boxes | 2014-12-11 |
| 2007-10-23 | Not classified | Other | Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions. | 500/1-ml packs | 2008-07-16 |
| 2007-10-23 | Not classified | Other | Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions. | 554/2-ml packs | 2008-07-16 |
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.