eMAG™ Tips 1000µL

GUDID 03573026489434

Specific tips for eMAG system which is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens. For in vitro diagnostic use

BIOMERIEUX SA

Pipette tip IVD

• Primary Device ID: 03573026489434
• NIH Device Record Key: 61a96dfc-6e43-4eef-ae14-8b454a28d760
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eMAG™ Tips 1000µL
• Version Model Number: eMAG™ Tips 1000µL
• Company DUNS: 276816717
• Company Name: BIOMERIEUX SA
• Device Count: 96
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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	03573026489434 [Package]; Contains: 03573026615253; Package: [10 Units]; In Commercial Distribution
GS1	03573026615246 [Unit of Use]
GS1	03573026615253 [Primary]

FDA Product Code

• JJH: CLINICAL SAMPLE CONCENTRATOR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-01-25
• Device Publish Date: 2020-05-20

Devices Manufactured by BIOMERIEUX SA

• 03573026626891 - VIDAS® TBI (GFAP, UCH-L1): 2024-11-08 VIDAS TBI (GFAP, UCH-L1) is an automated quantitative test to be used on VIDAS3. It is intended to be used as an aid in the eval
• 03573026359096 - VITEK® MS-DS: 2024-04-30 The VITEK MS-DS target slides enable the identification of microorganisms according to the MALDI-TOF mass spectrometry method.
• 03573026359119 - VITEK® MS: 2024-04-29 MALDI-Tof Mass Spectrometry system used for microbial identification
• 03573026362843 - VITEK® MS FA: 2024-04-29 VITEK ® MS - FA is used to pretreat yeasts to facilitate their identification according to the MALDI - TOF method. It is used e
• 03573026619527 - VIDAS® PC SOFTWARE V4.9: 2024-04-29 VIDAS PC V4.9 W10 Software version for clinic
• 03573026256685 - ETEST® Gentamicin (GM): 2024-04-15 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1
• 03573026376604 - ETEST® Amoxicillin (AC): 2024-04-15 Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 1
• 03573026377731 - ETEST® Flucytosine (FC): 2024-04-15 Etest is a quantitative technique for determining susceptibility of antifungal. It provides a gradient of 15 doubling dilutions