Identity
- Trade Name
- BioMAX FDA UDI
- Generic Name
- Oral/respiratory tract specimen container IVD, additive/medium FDA UDI
- Device Name
- The Spectrum Solutions BioMAX Specimen Collection device consists of a plastic tube designed for the collection of human saliva samples, a funnel, a cap with a stem flare, and a fluid chamber containing Spectrum’s inactivating media. Sample collection is conducted under the supervision of a Health care provider. The user deposits their saliva into the collection tube with the aid of the attached funnel, the user removes the funnel and replaces it with the cap. Upon twisting and closing the cap, the stabilizing solution is released into the tube and mixed with the saliva. FDA UDI
- Model / Reference
- SDNA 1000 FDA UDI
- Description
- The Spectrum Solutions BioMAX Specimen Collection device consists of a plastic tube designed for the collection of human saliva samples, a funnel, a cap with a stem flare, and a fluid chamber containing Spectrum’s inactivating media. Sample collection is conducted under the supervision of a Health care provider. The user deposits their saliva into the collection tube with the aid of the attached funnel, the user removes the funnel and replaces it with the cap. Upon twisting and closing the cap, the stabilizing solution is released into the tube and mixed with the saliva. FDA UDI
Identifiers
- Catalog Number
- 2019162 FDA UDI
- Primary DI / UDI-DI
- 00850015033001 FDA UDI
- 510(k) Number
- K223497 FDA UDI
- FDA Product Code
- QBD FDA UDI
- GMDN Term
- Oral/respiratory tract specimen container IVD, additive/medium FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.2950 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Oral/respiratory tract specimen container IVD, additive/medium
BioMAX by Spectrum Solutions L.L.C. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oral/respiratory tract specimen container IVD, additive/medium.
- PrimeStore MTM — Longhorn Vaccines and Diagnostics LLC · Class II
- SalivaGene Collector — Invitek Molecular GmbH · Class I
- SalivaGene Swab Comfort — Invitek Molecular GmbH · Class I
- SpeciMAX Dx Stabilized Saliva Collection Kit — LIFE TECHNOLOGIES LIMITED · Class I
- R12576 M4RTUniversal Plus Swab Kit PK/100 — REMEL, INC. · Class I
- BioSci™ — Shenzhen Dakewe Bio-engineering Co., Ltd · Class II
- PrimeStore MTM — Longhorn Vaccines and Diagnostics LLC · Class II
- Dakewe — SHENZHEN DAKEWE BIO-ENGINEERING CO., LTD. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spectrum Solutions L.L.C.
Sources (1)
- FDA UDI 886528d7-c40f-40f8-a917-5364fe1fff42 37 fields · synced Jun 1, 2026