Vitros 6801703

by Ortho-Clinical Diagnostics

Vitros 6801703 is a Class II device made by Ortho-Clinical Diagnostics, listed in FDA GUDID since 10 Aug 2016 (UDI-DI 10758750006670), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10758750006670 UDI-DI	Date10 Aug 2016Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 10758750006670

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Vitros
Generic name: Low density lipoprotein (LDL) cholesterol IVD, calibrator
Model / Ref / Catalog: 6801703

Primary DI / UDI-DI: 10758750006670
FDA product code: JIT
GMDN term: Low density lipoprotein (LDL) cholesterol IVD, calibrator

Device class: Class II
Regulation number: 862.1150
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Convenience kit
Lot / batch number
Expiration date

Other properties (11, all answered No)