FDA UDI
In Commercial Distribution
🇺🇸 United States
Birlinn™ CoV2-Flu-RSV Control Panel M509
DI: 00852720008244
·
Model: v.00
·
Mmqci
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Birlinn™ CoV2-Flu-RSV Control Panel M509
- Primary DI
- 00852720008244
- Version / Model
- v.00
- Catalog Number
- M509
- Company Name
- Mmqci
- Labeler DUNS
- 172874245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-04
- Public Version
- 1
- Public Version Date
- 2025-12-12
- Public Version Status
- New
- Public Device Record Key
- 480a1ab7-4345-4d94-ad4b-3a319ef6fcad
Device Description
External qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of SARS-CoV-2, FluA, FluB, RSV A and RSV B.
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
- Yes
- 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 |
|---|---|---|---|---|
| OHQ | Multi-Analyte Controls Unassayed | Clinical Chemistry | 862.1660 | 1 |
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 | 00852720008244 | GS1 |
Customer Contacts
- Phone
- 207-885-1072
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius