Whole Saliva Collection Kit

INTENDED USE:
The saliva collection system is designed for self-contained saliva sample collection which provides critical sample consistency while amplifying, preserving, and protecting transcripts at the point of collection for highly sensitive and highly specific analysis. Sample self-collection using a saliva collection kit provides 100% in-device live viral neutralization in 10 seconds at room temperature, mitigating any risk of exposure for downstream processes. The saliva kits have no special storage or transport temperature-control requirements for collected saliva samples and eliminate the need for UN3373 biohazard shipping designation with clearance from USPS, FedEx, & UPS.

FEATURES:

First FDA Authorized COVID-19 saliva testing solution
First FDA Authorized at-home saliva collection device for COVID-19 testing.
Identify infections at their earliest stage before the onset of symptoms.
In-device 100% inactivation of the live virus within the device at ambient temps
Maintains critical bio-sample consistency.
99.998% testing accuracy & more sensitive
No temperature-controlled storage or sample transport
Post-collection stability with no degradation in sample efficacy
Process multiple tests from a single collected sample
Eliminate the need for UN3373 shipping designation.
Supported system and validated testing process.
At-home and direct-to-patient fulfillment
simplicity and effectiveness of saliva collection devices have delivered a new standard of care for patients and laboratories.

SKU: SDNA-1000 / SDNA-2000 / SDNA-3000 Rx only Categories: Clinical Diagnostics, Specimens Collection

$9.99 – $12.99

Product No

SDNA-1000
SDNA-2000
SDNA-3000 Rx only

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Description

ORDER INFORMATION:

Cat. #	Description	Qty.
SDNA-1000	Saliva Collection Device for FDA 510k Cleared DNA & RNA molecular diagnostic testing, specimen collection and extended analyte preservation at ambient temperatures.	1/kit
SDNA-2000	Saliva Collection Device, for DNA & RNA molecular diagnostic testing. CE mark approved and authorized.	1/kit
SDNA-3000 (Rx Only)	Saliva Collection Device, for Rx Only – DNA & RNA molecular diagnostic testing. CE mark approved and authorized.	1/kit

SPECIFICATIONS:

Simplify the collection of saliva for commercial bioinformatic DNA testing applications, academic, research, biobanking, and as a bio-sample collection option for viral DNA/RNA COVID-19 testing for hospital networks, health departments and clinical research organizations with Spectrum™ Solutions SDNA Whole Saliva Collection Device.

Single device for DNA/viral RNA bio sample collection, transportation, & storage.
Intuitive 3-step design, proven to reduce customer collection errors.
System maintains bio sample consistency.
Significantly reduces costs associated with sample failures & recollection.
Tube compatible with automated platforms.
Innovative, patented chemistry that preserves & protects both DNA/viral RNA transcripts, manages bacteria & mitigates any risk of infection throughout the testing process.

APPLICATIONS:

SDNA-1000 Saliva Collection Device —-FDA 510k Cleared DNA & RNA Molecular Diagnostic Testing

[2023] FDA Class II Medical Device Clearance
[2020] The FDA has granted special authorization (EUA202432) and device use for COVID-19 testing beyond research-only applications to additionally include clinical diagnostics. COVID-19 saliva-based diagnostic testing

SDNA-2000 Saliva Collection Device—-DNA & RNA Molecular Diagnostic Testing