FDA UDI
In Commercial Distribution
🇺🇸 United States
SPOTFIRE RSP Pos & Neg Controls
DI: 00852720008145
·
Model: v.00
·
Mmqci
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SPOTFIRE RSP Pos & Neg Controls
- Primary DI
- 00852720008145
- Version / Model
- v.00
- Catalog Number
- M425
- Company Name
- Mmqci
- Labeler DUNS
- 172874245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-18
- Public Version
- 1
- Public Version Date
- 2025-06-26
- Public Version Status
- New
- Public Device Record Key
- fe7dd84f-eb99-4d8f-9585-5ea7917e7c4a
Device Description
POS and NEG external qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of pathogens included in BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini, BIOFIRE SPOTFIRE R/ST Panel and BIOFIRE SPOTFIRE R/ST Panel Mini
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 |
|---|---|---|---|---|
| 47920 | Multiple-genus respiratory virus 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 virus genera associated with respiratory disease in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852720008145 | GS1 |
Customer Contacts
- Phone
- 207-885-1072
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241289 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius