FDA UDI
In Commercial Distribution
🇺🇸 United States
BioFire JI Control Panel M420
DI: 00852720008121
·
Model: v.00
·
Mmqci
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BioFire JI Control Panel M420
- Primary DI
- 00852720008121
- Version / Model
- v.00
- Catalog Number
- M420
- Company Name
- Mmqci
- Labeler DUNS
- 172874245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-14
- Public Version
- 1
- Public Version Date
- 2022-11-22
- Public Version Status
- New
- Public Device Record Key
- 09b3931e-a647-452f-9594-be82efecc3cd
Device Description
External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures on the BioFire Joint Infection Panel on the BioFire FilmArray systems.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 48114 | Escherichia coli nucleic acid IVD, control | A material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative detection of nucleic acid from Escherichia coli (E. coli) bacteria in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852720008121 | GS1 |
Customer Contacts
- Phone
- 207-885-1072
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203680 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius