Streck Viral Extraction Kit 250074

GUDID 00844509002376

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.

STRECK, INC.

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 00844509002376
• NIH Device Record Key: 21350f70-6f62-4226-8a33-c5017346b9bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streck Viral Extraction Kit
• Version Model Number: 250074
• Catalog Number: 250074
• Company DUNS: 072915986
• Company Name: STRECK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 180 Milliliter
• Total Volume: 180 Milliliter
• Total Volume: 180 Milliliter
• Total Volume: 180 Milliliter
• Total Volume: 180 Milliliter
• Total Volume: 180 Milliliter
• Total Volume: 180 Milliliter
• Total Volume: 180 Milliliter
• Total Volume: 180 Milliliter
• Total Volume: 180 Milliliter
• Total Volume: 180 Milliliter
• Total Volume: 180 Milliliter
• Total Volume: 180 Milliliter
• Total Volume: 180 Milliliter
• Total Volume: 180 Milliliter
• Total Volume: 180 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844509002376 [Primary]

FDA Product Code

• JJH: Clinical Sample Concentrator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-21
• Device Publish Date: 2023-06-13

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