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Dimension Vista®Apolipoprotein B Flex® reagent cartridge
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Dimension Vista®Apolipoprotein B Flex® reagent cartridge FDA UDI
- Generic Name
- Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- For the quantitative measurement of apolipoprotein B in human serum and plasma on the Dimension Vista® System FDA UDI
- Model / Reference
- 10445887 FDA UDI
- Description
- For the quantitative measurement of apolipoprotein B in human serum and plasma on the Dimension Vista® System FDA UDI
Identifiers
- Catalog Number
- K7020 FDA UDI
- Primary DI / UDI-DI
- 00842768006029 FDA UDI
- 510(k) Number
- K063608 FDA UDI
- FDA Product Code
- MSJ FDA UDI
- GMDN Term
- Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1475 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry
Dimension Vista®Apolipoprotein B Flex® reagent cartridge by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry.
- Tinaquant Apolipoprotein B ver2 — Roche Diagnostics Corp. · Class II
- Tinaquant Apolipoprotein B ver2 — Roche Diagnostics Corp. · Class II
- ARCHITECT — Abbott · Class II
- VITROS — Ortho-Clinical Diagnostics · Class I
- Alinity — Abbott · Class II
- APO B — Randox Laboratories, Ltd. · Class I
- APO B — Randox Laboratories, Ltd. · Class I
- Tina-quant Apolipoprotein B ver.2 — Roche Diagnostics Corp. · Class II
Cleared under the same submission
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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI d7c2b6ae-8a92-4bce-90ce-1e276214997a 37 fields · synced May 30, 2026