FDA UDI
In Commercial Distribution
🇺🇸 United States
FilmArray® Meningitis/Encephalitis (ME) Panel
DI: 00815381020130
·
Model: RFIT-ASY-0119
·
BIOFIRE DIAGNOSTICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FilmArray® Meningitis/Encephalitis (ME) Panel
- Primary DI
- 00815381020130
- Version / Model
- RFIT-ASY-0119
- Catalog Number
- RFIT-ASY-0119
- Company Name
- BIOFIRE DIAGNOSTICS, LLC
- Labeler DUNS
- 079280262
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 6
- Public Version Date
- 2020-12-21
- Public Version Status
- Update
- Public Device Record Key
- b8e67541-affd-4aa0-8841-4eb027a63894
Device Description
IVD reagent kit containing 6 tests.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| PLO | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | Microbiology | 866.3970 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61043 | Multiple-type meningitis 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 acid from multiple types of pathogens associated with meningitis, in a clinical specimen, using a nucleic acid technique (NAT). Pathogens detected may include but are not limited to Streptococcus meningitidis, Neisseria meningitidis, Haemophilus influenzae, adenovirus, enterovirus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2), varicella-zoster virus (VZV), and Mumps virus. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815381020130 | GS1 |