MultiCode® Chlamydophila pneumoniae Primers 3925

GUDID 00840487100233

Nucleic acid sequences, which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens

LUMINEX CORPORATION

Multiple respiratory disease-associated bacteria nucleic acid IVD, reagents

• Primary Device ID: 00840487100233
• NIH Device Record Key: 1f51cdec-f14e-4bed-bf3e-84f1802250cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MultiCode® Chlamydophila pneumoniae Primers
• Version Model Number: 3925
• Catalog Number: 3925
• Company DUNS: 079686463
• Company Name: LUMINEX CORPORATION
• 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com
• Phone: +1(866)327-3290
• Email: support@luminexcorp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Celsius and -15 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840487100233 [Primary]

FDA Product Code

• MVU: REAGENTS,SPECIFIC,ANALYTE

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: 2018-03-29
• Device Publish Date: 2016-12-16

Devices Manufactured by LUMINEX CORPORATION

• 00840487101858 - LIAISON PLEX Gram-Positive Blood Culture Assay: 2025-07-21 The LIAISON PLEX® Gram-Positive Blood Culture (BCP) Assay, performed using the automated, sample-to-result LIAISON PLEX® Syste
• 00840487101841 - LIAISON PLEX Gram-Negative Blood Culture Assay: 2025-06-19 The LIAISON PLEX® Gram-Negative Blood Culture (BCN) Assay, performed using the automated, sample-to-result LIAISON PLEX® Syste
• 00840487101865 - LIAISON PLEX Yeast Blood Culture Assay Kit: 2024-10-30 The LIAISON PLEX® Yeast Blood Culture (BCY) Assay is a qualitative nucleic acid multiplex in vitro diagnostic test intended for
• 00840487101940 - LIAISON PLEX® Respiratory Flex Assay Kit: 2024-06-28 The LIAISON PLEX® Respiratory Flex (RSP Flex) Assay is a multiplexed qualitative test for the simultaneous in vitro detection a
• 00840487101957 - LIAISON PLEX® Chassis: 2024-06-28 The LIAISON PLEX® is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The
• 00840487101964 - LIAISON PLEX® Chassis (Refurbished): 2024-06-28 The LIAISON PLEX® is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests in clinical laboratories. The
• 00840487101971 - LIAISON PLEX® Module: 2024-06-28 The LIAISON PLEX® Module is a component of the LIAISON PLEX® Chassis. When installed in the LIAISON PLEX® Chassis it is capa
• 00840487101988 - LIAISON PLEX® Module (Refurbished): 2024-06-28 The LIAISON PLEX® Module is a component of the LIAISON PLEX® Chassis. When installed in the LIAISON PLEX® Chassis it is capa