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CalSet Vitamin D total III

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
CalSet Vitamin D total III FDA UDI
Generic Name
Multiple form 25-hydroxy Vitamin D IVD, calibrator FDA UDI
Device Name
Vitamin D total G3 CS Elecsys FDA UDI
Model / Reference
09038116190 FDA UDI
Description
Vitamin D total G3 CS Elecsys FDA UDI

Identifiers

Catalog Number
09038116190 FDA UDI
Primary DI / UDI-DI
07613336172667 FDA UDI
FDA Product Code
JIT FDA UDI
GMDN Term
Multiple form 25-hydroxy Vitamin D IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple form 25-hydroxy Vitamin D IVD, calibrator

CalSet Vitamin D total III by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple form 25-hydroxy Vitamin D IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI dee20418-c53b-46b3-94c6-ccd2d9f9cce5 34 fields · synced May 30, 2026