Identity
- Trade Name
- QSight(tm) 210 Screening System FDA UDI
- Generic Name
- Mass spectrometry analyser IVD FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- BC004945 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812589020320 FDA UDI
- FDA Product Code
- DOP FDA UDI
- GMDN Term
- Mass spectrometry analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mass spectrometry analyser IVD
QSight(tm) 210 Screening System by Perkinelmer Health Sciences Canada, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Perkinelmer Health Sciences Canada, Inc
Sources (1)
- FDA UDI a01781ea-b2c8-462c-8afb-8aca588006aa 33 fields · synced Jun 8, 2026