Remel
Acridine Orange, Phenolic Decol BTL/250ml
7manufacturers in China registered for this device type
45catalogue numbers in this listing
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 | 2023-01-04 |
| Record revised | 2025-03-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-04-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R40181 | In distribution | |
| R064446 | In distribution | |
| R064462 | In distribution | |
| R21099 | In distribution | |
| R09971 | In distribution | |
| R21248 | In distribution | |
| R064442 | In distribution | |
| R21369 | In distribution | |
| R065270 | In distribution | |
| R07140 | In distribution | |
| R20018 | In distribution | |
| R064436 | In distribution | |
| R065272 | In distribution | |
| R064464 | In distribution | |
| R064434 | In distribution | |
| R065262 | In distribution | |
| R07141 | In distribution | |
| R21370 | In distribution | |
| R14503 | In distribution | |
| R064439 | In distribution | |
| R064438 | In distribution | |
| R21096 | In distribution | |
| R21256 | In distribution | |
| R064430 | In distribution | |
| R21368 | In distribution | |
| R21076 | In distribution | |
| R21285 | In distribution | |
| R064450 | In distribution | |
| R21236 | In distribution | |
| R21249 | In distribution | |
| R08194 | In distribution | |
| R08432 | In distribution | |
| R20112 | Withdrawn | |
| R064448 | Withdrawn | |
| R21266 | Withdrawn | |
| R064432 | Withdrawn | |
| R21195 | Withdrawn | |
| R21270 | Withdrawn | |
| R064444 | Withdrawn | |
| R064468 | Withdrawn | |
| R09652 | Withdrawn | |
| R07142 | Withdrawn | |
| R21262 | Withdrawn | |
| R07300 | Withdrawn | |
| R08756 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Inoculating Loop 10ul Typenex | Zhejiang Runlab Technology Co., Ltd. | 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.