QBD · Microbial Nucleic Acid Storage And Stabilization Device

Device class

Class II

Regulation 866.2950

Total clearances

2020-09-17 → 2025-05-27

Last 12 months

Unique sponsors

Definition

What is Microbial Nucleic Acid Storage And Stabilization Device

Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.

Classification details

Medical specialty

Microbiology

Review panel

Regulation number

866.2950

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Most recent
Zymo Research	2	2023-09-28
Ningbo Dasky Life Science Co., Ltd.	1	2022-08-08
Fertipro NV	1	2024-06-11
Mawi Dna Technologies	1	2023-04-03
Hangzhou Bioer Technology Co., Ltd.	1	2024-06-26
Magbio Genomics, Inc.	1	2022-07-28
Zhejiang Gene Science Co., Ltd.	1	2024-04-08
Shenzhen Dakewe Bio-Engineering Co., Ltd.	1	2023-01-19
Spectrum Solutions, LLC	1	2023-02-17
Puritan Medical Products, LLC	1	2025-05-27
Wuxi Nest Biotechnology Co., Ltd.	1	2021-09-20
Copan Italia Spa	1	2020-09-17
Aardvark Medical, Inc.	1	2023-07-03
Permantis Public Health	1	2024-10-11
Alb Luz	1	2024-06-17

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.

Code	Type	Description	Confidence	Rationale
36415	CPT	—	Medium	Venipuncture for collection of sample for molecular testing; collection of nucleic acids
88199	CPT	—	Medium	Unlisted cytopathology procedure; nucleic acid storage/stabilization

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2025-05-27	K242820	Puritan Medical Products, LLC	Puritan PurSafe Plus Collection and Transport System
2024-10-11	K240797	Permantis Public Health	PPH Saliva Collection Kit
2024-06-26	K222771	Hangzhou Bioer Technology Co., Ltd.	Sample Preservative Fluid
2024-06-17	K233324	Alb Luz	Molecular Transport Media - MTM
2024-06-11	K221547	Fertipro NV	InActiv Blue
2024-04-08	K212878	Zhejiang Gene Science Co., Ltd.	Sample preservation solution
2023-09-28	K231013	Zymo Research	DNA/RNA Shield SafeCollect Saliva Collection kit
2023-07-03	K221664	Aardvark Medical, Inc.	CLEARinse CTS Specimen Collection and Transport System
2023-04-03	K221802	Mawi Dna Technologies	iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
2023-02-17	K223497	Spectrum Solutions, LLC	Spectrum Saliva Collection Device
2023-01-19	K220059	Shenzhen Dakewe Bio-Engineering Co., Ltd.	Biosci Inactivated Transport Medium, Biosci ITM
2022-08-08	K211675	Ningbo Dasky Life Science Co., Ltd.	Dasky Disposable Sampling Tube (Model name: VSM02)
2022-07-28	K212113	Magbio Genomics, Inc.	MagXtract Collection Tube
2021-09-20	K210440	Wuxi Nest Biotechnology Co., Ltd.	Disposable Sampler Inactivated Transport Media, Nest ITM
2020-12-14	K202641	Zymo Research	DNA/RNA Shield Collection Tube
2020-09-17	K201849	Copan Italia Spa	eNAT molecular collection and preservation medium