FDA UDI
In Commercial Distribution
🇺🇸 United States
Citrine QTRAP MS/MS
DI: 00842365100540
·
Model: 5050807
·
AB SCIEX (MANUFACTURING)
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Citrine QTRAP MS/MS
- Primary DI
- 00842365100540
- Version / Model
- 5050807
- Company Name
- AB SCIEX (MANUFACTURING)
- Labeler DUNS
- 595281292
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-28
- Public Version
- 1
- Public Version Date
- 2022-10-06
- Public Version Status
- New
- Public Device Record Key
- e28081d8-48e3-4a0f-84ad-a7b06ac9861f
Device Description
The Citrine system is a liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems intended to identify inorganic or organic compounds in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical field according to their mass.
Device Characteristics
- Single Use
- No
- 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
- 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 | 00842365100540 | GS1 |