FDA UDI
In Commercial Distribution
🇺🇸 United States
LIAISON Q.S.E.T. Device Plus
DI: 08056771602884
·
Model: 319060
·
Diasorin Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LIAISON Q.S.E.T. Device Plus
- Primary DI
- 08056771602884
- Version / Model
- 319060
- Company Name
- Diasorin Inc.
- Labeler DUNS
- 033429783
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-09
- Public Version
- 1
- Public Version Date
- 2022-08-17
- Public Version Status
- New
- Public Device Record Key
- 137cca98-5846-4fec-bbb2-a01a52db8d9e
Device Description
Fecal extraction device
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| NXO | Calprotectin, Fecal | Immunology | 866.5180 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53627 | Calprotectin IVD, reagent | A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of calprotectin protein in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056771602884 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213858 | 000 |