EchoLUTION Viral RNA/DNA Kit (8 x 48) 012-051-008-Dx

GUDID 04260759850189

BioEcho Life Sciences GmbH

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 04260759850189
• NIH Device Record Key: df4b4409-3242-4d0b-b591-a60bd1a78902
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EchoLUTION Viral RNA/DNA Kit (8 x 48)
• Version Model Number: 012-051-008-Dx
• Catalog Number: 012-051-008-Dx
• Company DUNS: 314351906
• Company Name: BioEcho Life Sciences GmbH
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04260759850189 [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: 2023-11-24
• Device Publish Date: 2023-11-16

Devices Manufactured by BioEcho Life Sciences GmbH

• 04260759850172 - EchoLUTION Viral RNA/DNA Kit (2 x 48): 2023-11-24
• 04260759850189 - EchoLUTION Viral RNA/DNA Kit (8 x 48): 2023-11-24
• 04260759850189 - EchoLUTION Viral RNA/DNA Kit (8 x 48): 2023-11-24
• 04260759850196 - EchoLUTION Viral RNA/DNA Kit (16 x 48): 2023-11-24
• 04260759850202 - EchoLUTION Viral RNA/DNA Kit (2 x 96): 2023-11-24
• 04260759850219 - EchoLUTION Viral RNA/DNA Kit (8 x 96): 2023-11-24
• 04260759850226 - EchoLUTION Viral RNA/DNA Kit (16 x 96): 2023-11-24