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Tina-Quant Apolipoprotein B Ver.2

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K013206

by Roche Diagnostics Corp.

Identity

Trade Name
Tinaquant Apolipoprotein B ver2 FDA UDI
Generic Name
Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry FDA UDI
Model / Reference
6301711190 FDA UDI

Identifiers

Catalog Number
6301711190 FDA UDI
Primary DI / UDI-DI
04015630930234 FDA UDI
510(k) Number
K013206 FDA 510(k)FDA UDI
FDA Product Code
DFC FDA 510(k)FDA UDI
GMDN Term
Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 866.5600 FDA 510(k)
Regulation Number
866.5600 FDA 510(k)FDA UDI
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Tina-Quant Apolipoprotein B Ver.2 by Roche Diagnostics Corp. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (2)

  • FDA 510(k) K013206 24 fields · synced Jun 18, 2026
  • FDA UDI 5017d717-a960-455a-9c13-36985ec4112b 35 fields · synced May 26, 2026