FDA UDI
In Commercial Distribution
🇺🇸 United States
LIAISON PLEX Yeast Blood Culture Assay Kit
DI: 00840487101865
·
Model: 20-005-306
·
LUMINEX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LIAISON PLEX Yeast Blood Culture Assay Kit
- Primary DI
- 00840487101865
- Version / Model
- 20-005-306
- Catalog Number
- 20-005-306
- Company Name
- LUMINEX CORPORATION
- Labeler DUNS
- 080778937
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-22
- Public Version
- 2
- Public Version Date
- 2026-03-24
- Public Version Status
- Update
- Public Device Record Key
- b9fdcdff-62e8-49f5-a5c5-bdde51fe98f7
Device Description
The 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PEO | Fungal Organisms, Nucleic Acid-Based Assay | Microbiology | 866.3365 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62484 | Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorgansims associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840487101865 | GS1 |
Customer Contacts
- Phone
- +1(877)785-2323
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240627 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius