Remel
DNase Test Agar, Methyl Green(slant)20/PK
2manufacturers in China registered for this device type
118catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| HBH Biotechnology Limited | Yantai | Shandong | Repacker / relabeller | 6 |
Record
| Listed by | Remel, Inc., United States |
|---|---|
| FDA product code | JSF |
| Device type | Culture Media, Single Biochemical Test |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2320 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-23 |
| Record revised | 2023-01-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-04-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R061548 | In distribution | |
| R062776 | In distribution | |
| R062342 | In distribution | |
| R061462 | In distribution | |
| R20388 | In distribution | |
| R062632 | In distribution | |
| R060146 | In distribution | |
| R060012 | In distribution | |
| R064022 | In distribution | |
| R062412 | In distribution | |
| R060496 | In distribution | |
| R062638 | In distribution | |
| R064052 | In distribution | |
| R062432 | In distribution | |
| R060494 | In distribution | |
| R060878 | In distribution | |
| R060174 | In distribution | |
| R061400 | In distribution | |
| R060972 | In distribution | |
| R061919 | In distribution | |
| R060170 | In distribution | |
| R061951 | In distribution | |
| R061172 | In distribution | |
| R061536 | In distribution | |
| R01688 | In distribution | |
| R060118 | In distribution | |
| R061916 | In distribution | |
| R064532 | In distribution | |
| R062786 | In distribution | |
| R060178 | In distribution | |
| R01850 | In distribution | |
| R062326 | In distribution | |
| R060596 | In distribution | |
| R060158 | In distribution | |
| R062636 | In distribution | |
| R065210 | In distribution | |
| R061392 | In distribution | |
| R062242 | In distribution | |
| R065212 | In distribution | |
| R062224 | In distribution | |
| R060114 | In distribution | |
| R061150 | In distribution | |
| R061990 | In distribution | |
| R061414 | In distribution | |
| R065232 | In distribution | |
| R061918 | In distribution | |
| R07774 | In distribution | |
| R060130 | In distribution | |
| R060620 | In distribution | |
| R061954 | In distribution | |
| R061326 | In distribution | |
| R062032 | In distribution | |
| R061998 | In distribution | |
| R062564 | In distribution | |
| R062442 | In distribution | |
| R065222 | In distribution | |
| R060110 | In distribution | |
| R060022 | In distribution | |
| R061140 | In distribution | |
| R061950 | In distribution | |
| R061394 | In distribution | |
| R060162 | In distribution | |
| R21128 | In distribution | |
| R062630 | In distribution | |
| R062402 | In distribution | |
| R062796 | In distribution | |
| R061170 | In distribution | |
| R060106 | In distribution | |
| R062352 | In distribution | |
| R060124 | In distribution | |
| R064548 | In distribution | |
| R060192 | In distribution | |
| R062322 | In distribution | |
| R060616 | In distribution | |
| R09512 | In distribution | |
| R060952 | In distribution | |
| R060660 | In distribution | |
| R064854 | In distribution | |
| R064072 | In distribution | |
| R062452 | In distribution | |
| R062182 | In distribution | |
| R062332 | In distribution | |
| R01854 | In distribution | |
| R061412 | In distribution | |
| R060588 | In distribution | |
| R062272 | In distribution | |
| R061946 | In distribution | |
| R061100 | Withdrawn | |
| R061096 | Withdrawn | |
| R21276 | Withdrawn | |
| R060876 | Withdrawn | |
| R060166 | Withdrawn | |
| R09776 | Withdrawn | |
| R061534 | Withdrawn | |
| R065314 | Withdrawn | |
| R062806 | Withdrawn | |
| R065230 | Withdrawn | |
| R061410 | Withdrawn | |
| R09892 | Withdrawn | |
| R061408 | Withdrawn | |
| R060154 | Withdrawn | |
| R060138 | Withdrawn | |
| R061152 | Withdrawn | |
| R07138 | Withdrawn | |
| R062252 | Withdrawn | |
| R065346 | Withdrawn | |
| R065350 | Withdrawn | |
| R061308 | Withdrawn | |
| R063042 | Withdrawn | |
| R01870 | Withdrawn | |
| R08026 | Withdrawn | |
| R08210 | Withdrawn | |
| R08342 | Withdrawn | |
| R20002 | Withdrawn | |
| R060668 | Withdrawn | |
| R060196 | Withdrawn | |
| R064042 | Withdrawn | |
| R065330 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Culture Media, Single Biochemical Test | Hardy Diagnostics | 69 |
| Redipor | Analytichem USA, Inc. | 8 |
| BD BBL™ Moeller Decarboxylase Broth Base | Becton, Dickinson AND Company | 1 |
| BD BBL™ CTA Medium™ | Becton, Dickinson AND Company | 1 |
| BD BBL™ Moeller Decarboxylase Broth with Arginine | Becton, Dickinson AND Company | 1 |
| LanaGram™ | Hardy Diagnostics | 1 |
| BD BBL™ Moeller Decarboxylase Broth with Ornithine | Becton, Dickinson AND Company | 1 |
| BD BBL™ CTA Medium™ with Sucrose | Becton, Dickinson AND Company | 1 |
| Spot Indole Reagent (10ml) | pro-lab incorporated | 1 |
| BD BBL™ CTA Medium™ with Lactose | Becton, Dickinson AND Company | 1 |
| BD BBL™ Moeller Decarboxylase Broth with Lysine | Becton, Dickinson AND Company | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K850194 | 1985-04-22 |
| K842297 | 1984-06-22 |
| K840685 | 1984-04-17 |
| K800287 | 1980-03-19 |
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.