Identity
- Trade Name
- Streck Viral Extraction Kit FDA UDI
- Generic Name
- Nucleic acid extraction/isolation kit IVD FDA UDI
- Device Name
- The Streck® Viral Extraction Kit is intended for use in isolating intact virus particles and associated viral nucleic acids (RNA) contained in clinical samples for use in Molecular Diagnostic Assays. Utilizing Ceres Nanotrap® Microbiome A Particles and Streck developed buffers, viral RNA extraction and purification is completed in less than 30 minutes. Eluted samples can then be utilized for downstream analysis or stored for later use. FDA UDI
- Model / Reference
- 250074 FDA UDI
- Description
- The Streck® Viral Extraction Kit is intended for use in isolating intact virus particles and associated viral nucleic acids (RNA) contained in clinical samples for use in Molecular Diagnostic Assays. Utilizing Ceres Nanotrap® Microbiome A Particles and Streck developed buffers, viral RNA extraction and purification is completed in less than 30 minutes. Eluted samples can then be utilized for downstream analysis or stored for later use. FDA UDI
Identifiers
- Catalog Number
- 250074 FDA UDI
- Primary DI / UDI-DI
- 00844509002376 FDA UDI
- FDA Product Code
- JJH FDA UDI
- GMDN Term
- Nucleic acid extraction/isolation kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 180 Milliliter FDA UDI
Category: Nucleic acid extraction/isolation kit IVD
Streck Viral Extraction Kit by Streck — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nucleic acid extraction/isolation kit IVD.
- Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
- abGenix™ Viral DNA and RNA Extraction Kit II (Plate) — AITbiotech Pte Ltd · Class A
- Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
- HPLC column — Immundiagnostik AG · Class A
- VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
- ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
- Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Streck
Sources (1)
- FDA UDI 21350f70-6f62-4226-8a33-c5017346b9bc 36 fields · synced May 31, 2026