← Back to catalogue
Gram-Negative Blood Culture (BC-GN) Extraction Tray
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Gram-Negative Blood Culture (BC-GN) Extraction Tray FDA UDI
- Generic Name
- Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed using the sample-to-result Verigene® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. FDA UDI
- Model / Reference
- 20-009-021 FDA UDI
- Description
- The Verigene® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) performed using the sample-to-result Verigene® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. FDA UDI
Identifiers
- Catalog Number
- 20-009-021 FDA UDI
- Primary DI / UDI-DI
- 00840487101643 FDA UDI
- 510(k) Number
- K132843 FDA UDI
- FDA Product Code
- PEN FDA UDI
- GMDN Term
- Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3365 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Gram-Negative Blood Culture (BC-GN) Extraction Tray by Luminex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT).
- STRAP AMSCO REPLACEMENT — AliMed, LLC · Class I
- T2Bacteria® Cartridge Kit — T2biosystems, Inc. · Class II
- Gram-Positive Blood Culture (BC-GP) Utility Tray — Luminex Corporation · Class II
- LIAISON PLEX Gram-Negative Blood Culture Assay — Luminex Corporation · Class II
- LIAISON PLEX Yeast Blood Culture Assay Kit — Luminex Corporation · Class II
- Gram-Negative Blood Culture (BC-GN) Utility Tray — Luminex Corporation · Class II
- LIAISON PLEX Gram-Positive Blood Culture Assay — Luminex Corporation · Class II
- Gram-Negative Blood Culture (BC-GN) Nucleic Acid Test Cartridge — Luminex Corporation · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Luminex Corporation
Sources (1)
- FDA UDI 7f6b132c-ea69-4c1c-8253-28cb9d38f1e0 37 fields · synced Jun 9, 2026