SearchBelow you’ll find every Invitek Diagnostics product currently listed with the U.S. FDA Device Registration & Listing / GUDID databases. Listing confirms the device may be legally marketed in the U.S. under its Class-I exemption, but it is not the same as a 510(k) clearance or PMA approval for a specific diagnostic claim. If you need any assistance to obtain further information about these kits, you can directly contact our authorized distributor for the US market: Zenith Molecular Solutions
1 · Specimen-Collection & Preservation Devices
| Brand (UDI) | Description | FDA Listing Details |
|---|---|---|
| SalivaGene Collector 04250306301219 |
Saliva tube pre-filled with stabilization buffer – for mail-in or on-site collection. | Listed 20 Feb 2025 · Class I “Oral/respiratory tract specimen container, non-sterile” |
| SalivaGene Swab Comfort 04250306301110 |
Soft oropharyngeal swab + collection tube/buffer set. | Listed 28 Nov 2024 · Class I specimen container |
2 · Manual / Semi-Automated Nucleic-Acid Extraction Kits
| Brand (UDI – Pack Size) | Intended Use | FDA Listing Details |
|---|---|---|
|
InviMag Universal Kit /KF96 04250306300724 InviMag Universal Kit /KF96 w/o plastic 04250306300823 |
Magnetic bead-based DNA/RNA extraction in 96-well plates; compatible with KingFisher™ instruments. |
Listed 9 Apr 2025 · Class I “General Purpose Reagent” (standard plastics)
Listed 9 Apr 2025 · Class I “General Purpose Reagent” (w/o plastic) |
|
InviTrap Spin Universal RNA Kit 04250306300212 (50 prep) 04250306300229 (250 prep) |
Column-based total RNA purification from diverse bio-fluids & tissues. |
Listed 28 Jan 2025 · Class I “Molecular Diagnostic Reagent” (50)
Listed 28 Jan 2025 · Class I “Molecular Diagnostic Reagent” (250) |
|
PSP SalivaGene DNA Kit 04250306300915 (50 prep) 04250306300922 (250 prep) |
Manual DNA isolation from stabilized saliva samples. |
Listed 10 Sep 2024 · Class I molecular reagent kit (50)
Listed 28 Jan 2025 · Class I molecular reagent kit (250) |
|
PSP Spin Stool DNA Basic Kit 04250306300410 (50 prep) 04250306300427 (250 prep) |
DNA extraction from faecal samples for pathogen or microbiome analysis. |
Listed 28 Jan 2025 · Class I molecular reagent kit (50)
Listed 28 Jan 2025 · Class I molecular reagent kit (250) |
|
RTP Pathogen Kit 04250306300311 (50 prep) 04250306300328 (250 prep) |
Magnetic-bead kit for high-throughput pathogen (DNA + RNA) extraction. |
Listed 28 Jan 2025 · Class I “General Purpose Reagent” (50)
Listed 28 Jan 2025 · Class I “General Purpose Reagent” (250) |
Need FDA-cleared diagnostic tests?
The items above are listed Class-I devices (510(k)-exempt). For assays that require FDA clearance, emergency use authorization, or PMA approval, please verify whether an additional submission exists for your intended diagnostic claim. As of 13 May 2025, no Invitek molecular kits have an FDA 510(k) clearance or EUA.
The items above are listed Class-I devices (510(k)-exempt). For assays that require FDA clearance, emergency use authorization, or PMA approval, please verify whether an additional submission exists for your intended diagnostic claim. As of 13 May 2025, no Invitek molecular kits have an FDA 510(k) clearance or EUA.