FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel
DI: 00851458005259
·
Model: DFA2-ASY-0006
·
BIOFIRE DEFENSE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel
- Primary DI
- 00851458005259
- Version / Model
- DFA2-ASY-0006
- Catalog Number
- DFA2-ASY-0006
- Company Name
- BIOFIRE DEFENSE, LLC
- Labeler DUNS
- 556915205
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-16
- Public Version
- 2
- Public Version Date
- 2023-03-29
- Public Version Status
- Update
- Public Device Record Key
- 4ce4946c-7539-48a4-9f67-a962a458f317
Device Description
BIOFIRE® SHIELD™ Control Kit for the BioFire Global Fever Panel - IVD Reagent External Control Kit
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 |
|---|---|---|---|---|
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | Microbiology | 866.3920 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61055 | Multiple-type tropical pathogen nucleic acid IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with febrile infection in tropical areas, in a clinical specimen. Organisms detected may include (but are not limited to) Dengue virus, Chikungunya virus, Salmonella spp, West Nile virus, Plasmodium spp., Rickettsia spp. and/or Leptospirosis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851458005259 | GS1 |
Customer Contacts
- Phone
- 801-262-3592
- [email protected]