Vitros

FDA UDI

Class II (US FDA UDI)

by Ortho-Clinical Diagnostics

Identity

Trade Name: VITROS FDA UDI
Generic Name: C-reactive protein (CRP) IVD, calibrator FDA UDI
Device Name: VITROS Chemistry Products hsCRP Performance Verifier II FDA UDI
Model / Reference: 6801888 FDA UDI
Description: VITROS Chemistry Products hsCRP Performance Verifier II FDA UDI

Identifiers

Catalog Number: 6801888 FDA UDI
Primary DI / UDI-DI: 10758750001637 FDA UDI
FDA Product Code: DCK FDA UDI
GMDN Term: C-reactive protein (CRP) IVD, calibrator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.5270 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: C-reactive protein (CRP) IVD, calibrator

Vitros by Ortho-Clinical Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as C-reactive protein (CRP) IVD, calibrator.

ADVIA® Chemistry Wide Range C-Reactive Protein Calibrators — Siemens Healthcare Diagnostics · Class II
CRP Ultra WR Calibrator — Sekisui Diagnostics, LLC · Class II
ABX Pentra CRP HS Cal — Horiba Abx · Class II
CRP CAL — Randox Laboratories, Ltd. · Class II
POINTE SCIENTIFIC CRP Calibrator Set (5, 20, 40, 160, 320 mg/L) — POINTE SCIENTIFIC, INC. · Class II
CRP CAL — Randox Laboratories, Ltd. · Class II
hsCRP CAL — Randox Laboratories, Ltd. · Class II
POINTE SCIENTIFIC CRP Standard Set (2.5, 10, 20, 80, 160 mg/L) — POINTE SCIENTIFIC, INC. · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Ortho-Clinical Diagnostics

Sources (1)

FDA UDI d7c2dcd4-404e-4739-842e-0d886db8896f 35 fields · synced Jun 6, 2026