Chrysalis Intelligence · Product Codes · JSM

JSM · Unclassified

21 clearances · 18 unique sponsors

Device class
Regulation —
Total clearances
21
2021-03-03 → 2025-11-26
Last 12 months
2
Unique sponsors
18
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Copan Italia Spa 3 0 2024-10-11
Shenzhen Dakewe Bio-Engineering Co., Ltd. 2 0 2024-08-19
Bioteke Corporation (Wuxi) Co., Ltd. 1 0 2022-05-04
Hangzhou AllTest Biotech Co., Ltd. 1 0 2025-04-04
Medschenker, Inc. 1 0 2023-05-03
Arx Sciences, Inc. 1 0 2024-03-19
Medical Wire & Equipment Company (Bath), Ltd. 1 1 2025-11-26
Huachenyang (Shenzhen) Technology Co. , Ltd. 1 0 2022-08-18
Zhejiang Gongdong Medical Technology Co., Ltd. 1 0 2022-11-17
Merit Medical Systems, Inc. 1 0 2021-03-03
Hardy Diagnostics 1 0 2024-08-02
Hanchang Medic Co., Ltd. (Han Chang Medic) 1 0 2024-07-15
Wuxi Nest Biotechnology Co., Ltd. 1 0 2022-05-20
Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. 1 0 2023-12-21
Ensol Biosciences, Inc. 1 0 2024-08-29
Jinan Babio Biotechnology Co., Ltd. 1 1 2025-09-22
Alb Luz 1 0 2024-05-03
Azer Scientific, Inc. 1 0 2024-04-11
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
87082 CPT Medium Non-propagating culture media for transport/identification in microbiology
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-11-26 K242976 Medical Wire & Equipment Company (Bath), Ltd. Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device
2025-09-22 K250205 Jinan Babio Biotechnology Co., Ltd. Babio® Virus Transport Kit (Non-inactivating)
2025-04-04 K242576 Hangzhou AllTest Biotech Co., Ltd. AllTest Viral Transport Medium
2024-10-11 K232565 Copan Italia Spa UriSponge™
2024-08-29 K220908 Ensol Biosciences, Inc. Ensol EnTM Specimen Collection and Transport System
2024-08-19 K240235 Shenzhen Dakewe Bio-Engineering Co., Ltd. OmniTrans Transport System
2024-08-02 K233534 Hardy Diagnostics Viral Transport Medium
2024-07-15 K233449 Hanchang Medic Co., Ltd. (Han Chang Medic) Avantik VTM
2024-05-03 K232454 Alb Luz Viral Transport Media (VTM)
2024-04-25 K232357 Copan Italia Spa Copan Universal Transport Medium (UTM-RT) System
2024-04-11 K202531 Azer Scientific, Inc. Azer Scientific Universal Transport Medium
2024-03-19 K231843 Arx Sciences, Inc. ARX Viral Transport Media Collection and Transport System
2023-12-21 K231027 Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. KaiBiLi Extended ViralTrans
2023-05-03 K212743 Medschenker, Inc. MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
2023-04-05 K230035 Shenzhen Dakewe Bio-Engineering Co., Ltd. BioSci™ Disposable Virus Sampling Tubes
2022-12-16 K220052 Copan Italia Spa Copan FecalSwab Collection, Transport and Preservation System
2022-11-17 K220739 Zhejiang Gongdong Medical Technology Co., Ltd. Disposable Urine Collection Tube
2022-08-18 K212856 Huachenyang (Shenzhen) Technology Co. , Ltd. iClean Viral Transport System (VTM-RT kit)
2022-05-20 K211256 Wuxi Nest Biotechnology Co., Ltd. Disposable Sampler Viral Transport Media
2022-05-04 K211707 Bioteke Corporation (Wuxi) Co., Ltd. BioTeke Sterile Disposable Virus Sampling Kit
2021-03-03 K201674 Merit Medical Systems, Inc. Cultura Collection and Transport System