FDA UDI
In Commercial Distribution
🇺🇸 United States
FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls Kit
DI: 00850056728409
·
Model: CP0007
·
Lumos Diagnostics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls Kit
- Primary DI
- 00850056728409
- Version / Model
- CP0007
- Catalog Number
- CP0007
- Company Name
- Lumos Diagnostics, Inc.
- Labeler DUNS
- 081135788
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-21
- Public Version
- 1
- Public Version Date
- 2023-12-29
- Public Version Status
- New
- Public Device Record Key
- 8fd4767c-60f8-4619-9629-aaf7216e78f7
Device Description
FebriDx® Bacterial / Non-Bacterial Point of Care Assay, External Controls Kit
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47869 | Multiple-type clinical chemistry analyte profile 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 multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850056728409 | GS1 |
Customer Contacts
- Phone
- 1-855-586-6739
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius