| Primary Device ID | 00840487101865 |
| NIH Device Record Key | b9fdcdff-62e8-49f5-a5c5-bdde51fe98f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LIAISON PLEX Yeast Blood Culture Assay Kit |
| Version Model Number | 20-005-306 |
| Catalog Number | 20-005-306 |
| Company DUNS | 080778937 |
| Company Name | LUMINEX CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
| Phone | +1(877)785-2323 |
| support@luminexcorp.com | |
| Phone | +1(877)785-2323 |
| support@luminexcorp.com | |
| Phone | +1(877)785-2323 |
| support@luminexcorp.com | |
| Phone | +1(877)785-2323 |
| support@luminexcorp.com | |
| Phone | +1(877)785-2323 |
| support@luminexcorp.com | |
| Phone | +1(877)785-2323 |
| support@luminexcorp.com | |
| Phone | +1(877)785-2323 |
| support@luminexcorp.com | |
| Phone | +1(877)785-2323 |
| support@luminexcorp.com | |
| Phone | +1(877)785-2323 |
| support@luminexcorp.com | |
| Phone | +1(877)785-2323 |
| support@luminexcorp.com | |
| Phone | +1(877)785-2323 |
| support@luminexcorp.com | |
| Phone | +1(877)785-2323 |
| support@luminexcorp.com | |
| Phone | +1(877)785-2323 |
| support@luminexcorp.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840487101865 [Primary] |
| PEO | Fungal Organisms, Nucleic Acid-Based Assay |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-30 |
| Device Publish Date | 2024-10-22 |
| 00840487101865 - LIAISON PLEX Yeast Blood Culture Assay Kit | 2024-10-30The LIAISON PLEX® Yeast Blood Culture (BCY) Assay is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on the LIAISON PLEX® System for simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture. |
| 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 |
| 00840487101797 - MAGPIX® Drive Fluid PLUS (4PK) | 2022-09-16 The MAGPIX Drive Fluid PLUS serves as the delivery medium that carries the sample to the optics component of the MAGPIX instrume |
| 00840487101803 - xMAP® Sheath Fluid PLUS | 2022-09-16 Sheath Fluid PLUS is the delivery medium of the sample to the optics component. |