FDA UDI
In Commercial Distribution
🇺🇸 United States
Gram-Positive Blood Culture (BC-GP) Utility Tray
DI: 00840487101674
·
Model: 20-011-018
·
LUMINEX CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Gram-Positive Blood Culture (BC-GP) Utility Tray
- Primary DI
- 00840487101674
- Version / Model
- 20-011-018
- Catalog Number
- 20-011-018
- Company Name
- LUMINEX CORPORATION
- Labeler DUNS
- 080778937
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-05
- Public Version
- 3
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- 95db4320-61a6-41f7-846f-e076f9eb4517
Device Description
The Verigene® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene® System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI).
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 |
|---|---|---|---|---|
| NQX | SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN | Microbiology | 866.1640 | 2 |
| PAM | Gram-positive bacteria and their resistance markers | 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 |
|---|---|---|---|---|---|---|
| Previous | 00857573006287 | GS1 | ||||
| Primary | 00840487101674 | GS1 |
Customer Contacts
- Phone
- +1(877)785-2323
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 8 Degrees Celsius