FDA UDI
In Commercial Distribution
🇺🇸 United States
QSight(tm) 210 Screening System
DI: 00812589020320
·
Model: BC004945
·
Perkinelmer Health Sciences Canada, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QSight(tm) 210 Screening System
- Primary DI
- 00812589020320
- Version / Model
- BC004945
- Company Name
- Perkinelmer Health Sciences Canada, Inc
- Labeler DUNS
- 202265331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-13
- Public Version
- 3
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- a01781ea-b2c8-462c-8afb-8aca588006aa
Device Description
The QSight™ 210 MD Screening System includes a semi-automated triple quadrupole detector intended to identify compounds in human samples by ionizing the compounds and separating the resulting ions by means of an electrical and magnetic field according to their mass. The QSight™ 210 MD Screening System is suitable for use in clinical settings and should be operated by qualified laboratory personnel.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DOP | Mass Spectrometer, Clinical Use | Clinical Chemistry | 862.2860 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57849 | Mass spectrometry analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative determination of the chemical composition of a clinical specimen by ionizing the specimen and separating the resulting ions according to mass using an electrical and magnetic field. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812589020320 | GS1 |