Remel
Plate Count Agar, Std Method(deep) 100/PK
18manufacturers in China registered for this device type
206catalogue numbers in this listing
1510(k) clearance
18recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (5), Guangdong (4). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Medico Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Ningbo Guangbo Medical Technology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 22 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Haimen Shengbang Laboratory Equipment Co., Ltd. | Haimen | Jiangsu | Manufacturer | 17 |
| Jiangsu Rongye Technology Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 16 |
| Changsha Renji Medical Equipment Co., Ltd. | Changsha | Hunan | Manufacturer | 15 |
Showing 12 of 18. All 18 manufacturers in China registered for Culture Media, Non-Selective And Non-Differential
Record
| Listed by | Remel, Inc., United States |
|---|---|
| FDA product code | JSG |
| Device type | Culture Media, Non-Selective And Non-Differential |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2300 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-23 |
| Record revised | 2024-05-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-03-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R061012 | In distribution | |
| R08722 | In distribution | |
| R08696 | In distribution | |
| R064902 | In distribution | |
| R01326 | In distribution | |
| R064805 | In distribution | |
| R01302 | In distribution | |
| R01330 | In distribution | |
| R065029 | In distribution | |
| R061202 | In distribution | |
| R08691 | In distribution | |
| R08846 | In distribution | |
| R01070 | In distribution | |
| R09640 | In distribution | |
| R01069 | In distribution | |
| R08652 | In distribution | |
| R08650 | In distribution | |
| R060264 | In distribution | |
| R08930 | In distribution | |
| R10150 | In distribution | |
| R064860 | In distribution | |
| R064722 | In distribution | |
| R08062 | In distribution | |
| R09747 | In distribution | |
| R064422 | In distribution | |
| R09746 | In distribution | |
| R065000 | In distribution | |
| R01486 | In distribution | |
| R01749 | In distribution | |
| R062754 | In distribution | |
| R01068 | In distribution | |
| R061347 | In distribution | |
| R01605 | In distribution | |
| R01064 | In distribution | |
| R064802 | In distribution | |
| R08502 | In distribution | |
| R064690 | In distribution | |
| R060230 | In distribution | |
| R08690 | In distribution | |
| R08052 | In distribution | |
| R10101 | In distribution | |
| R064720 | In distribution | |
| R01240 | In distribution | |
| R061128 | In distribution | |
| R01042 | In distribution | |
| R061572 | In distribution | |
| R01752 | In distribution | |
| R01603 | In distribution | |
| R061483 | In distribution | |
| R09744 | In distribution | |
| R08060 | In distribution | |
| R064422 | In distribution | |
| R04059 | In distribution | |
| R02055 | In distribution | |
| R08618 | In distribution | |
| R064862 | In distribution | |
| R01627 | In distribution | |
| R060260 | In distribution | |
| R09642 | In distribution | |
| R01697 | In distribution | |
| R01768 | In distribution | |
| R065025 | In distribution | |
| R07182 | In distribution | |
| R08132 | In distribution | |
| R060480 | In distribution | |
| R01606 | In distribution | |
| R02110 | In distribution | |
| R01303 | In distribution | |
| R08692 | In distribution | |
| R060258 | In distribution | |
| R08007 | In distribution | |
| R01640 | In distribution | |
| R061570 | In distribution | |
| R01354 | In distribution | |
| R08720 | In distribution | |
| R01917 | In distribution | |
| R065024 | In distribution | |
| R09558 | In distribution | |
| R060544 | In distribution | |
| R061580 | In distribution | |
| R07664 | In distribution | |
| R01300 | In distribution | |
| R01766 | In distribution | |
| R08570 | In distribution | |
| R09626 | In distribution | |
| R064730 | In distribution | |
| R01760 | In distribution | |
| R01800 | In distribution | |
| R01693 | In distribution | |
| R064892 | In distribution | |
| R07086 | In distribution | |
| R01750 | In distribution | |
| R061344 | In distribution | |
| R060482 | In distribution | |
| R064880 | In distribution | |
| R01136 | In distribution | |
| R08064 | In distribution | |
| R08066 | In distribution | |
| R10100 | In distribution | |
| R062756 | In distribution | |
| R060270 | In distribution | |
| R061010 | In distribution | |
| R07330 | In distribution | |
| R09654 | In distribution | |
| R061903 | In distribution | |
| R01130 | In distribution | |
| R062602 | In distribution | |
| R061346 | In distribution | |
| R060856 | In distribution | |
| R09620 | In distribution | |
| R01780 | In distribution | |
| R05047 | In distribution | |
| R07180 | In distribution | |
| R08500 | In distribution | |
| R07810 | In distribution | |
| R060322 | In distribution | |
| R060250 | In distribution | |
| R20360 | In distribution | |
| R060546 | In distribution | |
| R061582 | In distribution | |
| R01763 | In distribution | |
| R01695 | In distribution | |
| R01702 | In distribution | |
| R060572 | In distribution | |
| R07222 | In distribution | |
| R060540 | In distribution | |
| R01036 | In distribution | |
| R08562 | In distribution | |
| R061481 | In distribution | |
| R01132 | In distribution | |
| R061132 | In distribution | |
| R01308 | In distribution | |
| R01139 | In distribution | |
| R07178 | In distribution | |
| R064890 | In distribution | |
| R060232 | In distribution | |
| R09656 | In distribution | |
| R060280 | In distribution | |
| R07224 | In distribution | |
| R061902 | In distribution | |
| R04080 | In distribution | |
| R061032 | In distribution | |
| R060320 | In distribution | |
| R01065 | In distribution | |
| R01685 | In distribution | |
| R07092 | Withdrawn | |
| R064808 | Withdrawn | |
| R065026 | Withdrawn | |
| R07228 | Withdrawn | |
| R08659 | Withdrawn | |
| R061104 | Withdrawn | |
| R060282 | Withdrawn | |
| R01327 | Withdrawn | |
| R064732 | Withdrawn | |
| R060854 | Withdrawn | |
| R01921 | Withdrawn | |
| R08560 | Withdrawn | |
| R01301 | Withdrawn | |
| R05140 | Withdrawn | |
| R10110 | Withdrawn | |
| R07084 | Withdrawn | |
| R08572 | Withdrawn | |
| R05035 | Withdrawn | |
| R07595 | Withdrawn | |
| R10268 | Withdrawn | |
| R01296 | Withdrawn | |
| R061030 | Withdrawn | |
| R064482 | Withdrawn | |
| R064700 | Withdrawn | |
| R064900 | Withdrawn | |
| R01446 | Withdrawn | |
| R08716 | Withdrawn | |
| R05054 | Withdrawn | |
| R10244 | Withdrawn | |
| R05025 | Withdrawn | |
| R064882 | Withdrawn | |
| R060252 | Withdrawn | |
| R061136 | Withdrawn | |
| R064702 | Withdrawn | |
| R09566 | Withdrawn | |
| R05138 | Withdrawn | |
| R04061 | Withdrawn | |
| R064710 | Withdrawn | |
| R08240 | Withdrawn | |
| R060266 | Withdrawn | |
| R05055 | Withdrawn | |
| R060488 | Withdrawn | |
| R064804 | Withdrawn | |
| R060272 | Withdrawn | |
| R08932 | Withdrawn | |
| R08934 | Withdrawn | |
| R09506 | Withdrawn | |
| R060570 | Withdrawn | |
| R060542 | Withdrawn | |
| R09932 | Withdrawn | |
| R05046 | Withdrawn | |
| R07900 | Withdrawn | |
| R064712 | Withdrawn | |
| R07019 | Withdrawn | |
| R08556 | Withdrawn | |
| R09504 | Withdrawn | |
| R07174 | Withdrawn | |
| R065002 | Withdrawn | |
| R01039 | Withdrawn | |
| R01293 | Withdrawn | |
| R01761 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Culture Media, Non-Selective And Non-Differential | Hardy Diagnostics | 57 |
| Edge Biologicals Inc | Edge Biologicals, Inc. | 24 |
| Redipor | Analytichem USA, Inc. | 21 |
| C.d.rich | Chengdu Rich Science Industry Co., Ltd. | 21 |
| BioTeke | Bioteke Corporation (Wuxi) Co., Ltd. | 14 |
| BD BBL™ Trypticase™ Soy Broth | Becton, Dickinson AND Company | 7 |
| MicroScan | Beckman Coulter, Inc. | 6 |
| Sample Storage Reagent | Sansure Biotech Inc. | 5 |
| HardyFlask™ | Hardy Diagnostics | 5 |
| KaiBiLi Extended ViralTrans Saline | Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. | 5 |
| Keystone Nasal / Respiratory Specimen Collection Kit → 100 pack | Keystone Manufacturing | 4 |
| BD BBL™ Enriched Thioglycollate Medium | Becton, Dickinson AND Company | 4 |
Showing 12 of 90. All products under Culture Media, Non-Selective And Non-Differential
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K802415 | 1980-10-31 |
Recalls
18 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 |
|---|---|---|---|---|---|
| 2019-04-17 | Class II | Under Investigation by firm | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days. | 133 units | 2020-08-21 |
| 2019-04-17 | Class II | Under Investigation by firm | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days. | 8,615 units | 2020-08-21 |
| 2019-04-17 | Class II | Under Investigation by firm | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days. | 2,395 units | 2020-07-10 |
| 2019-04-17 | Class II | Under Investigation by firm | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days. | 952 units | 2020-07-10 |
| 2019-04-17 | Class II | Under Investigation by firm | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days. | 282 units | 2020-07-10 |
| 2019-04-17 | Class II | Under Investigation by firm | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days. | 2,263 units | 2020-07-10 |
| 2019-04-17 | Class II | Under Investigation by firm | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days. | 76 units | 2020-07-10 |
| 2019-04-17 | Class II | Under Investigation by firm | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days. | 1,069 units | 2020-07-10 |
| 2019-04-17 | Class II | Under Investigation by firm | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days. | 27 units | 2020-07-10 |
| 2019-04-17 | Class II | Under Investigation by firm | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days. | 1,205 units | 2020-08-21 |
| 2019-04-17 | Class II | Under Investigation by firm | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days. | 248 units | 2020-07-10 |
| 2019-04-17 | Class II | Under Investigation by firm | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days. | 736 units | 2020-07-10 |
| 2019-04-17 | Class II | Under Investigation by firm | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days. | 888 units | 2020-07-10 |
| 2019-04-17 | Class II | Under Investigation by firm | Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days. | 242 units | 2020-08-21 |
| 2018-08-13 | Class II | Under Investigation by firm | Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms. | 384 units | 2019-06-18 |
| 2018-08-13 | Class II | Under Investigation by firm | Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms. | 48 units | 2019-06-18 |
| 2018-08-13 | Class II | Under Investigation by firm | Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms. | 2730 units | 2019-06-18 |
| 2015-05-04 | Class II | Material/Component Contamination | Product may be contaminated with Listeria monocytogenes. | 845/10/10-plate pack cases | 2017-02-13 |
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.