Identity
- Trade Name
- Jasper HPLC System FDA UDI
- Generic Name
- High performance liquid chromatography analyser IVD FDA UDI
- Device Name
- The Jasper HPLC system is a high pressure liquid chromatography system for clinical use intended to separate one or more compounds from a solution by processing the mixture of compounds (solutes) through a column packed with a solid absorbent material (stationary phase) under the influence of a high pressure liquid (mobile phase). This system is intended to be used in tandem with a mass spectrometer system for compound detection. FDA UDI
- Model / Reference
- 5057029 FDA UDI
- Description
- The Jasper HPLC system is a high pressure liquid chromatography system for clinical use intended to separate one or more compounds from a solution by processing the mixture of compounds (solutes) through a column packed with a solid absorbent material (stationary phase) under the influence of a high pressure liquid (mobile phase). This system is intended to be used in tandem with a mass spectrometer system for compound detection. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842365100519 FDA UDI
- FDA Product Code
- KIE FDA UDI
- GMDN Term
- High performance liquid chromatography analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2260 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
Yes
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: High performance liquid chromatography analyser IVD
Jasper HPLC System by Ab Sciex (manufacturing) — 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
- Ab Sciex (manufacturing)
Sources (1)
- FDA UDI fe72a994-fc01-43c0-87c3-90c5d35492d6 33 fields · synced Jun 6, 2026