← Back to catalogue

Dimension® EXL™ Total Vitamin D

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® EXL™ Total Vitamin D FDA UDI
Generic Name
Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Dimension® EXL™ Total Vitamin D, 200 tests (4x50) FDA UDI
Model / Reference
10706480 FDA UDI
Description
Dimension® EXL™ Total Vitamin D, 200 tests (4x50) FDA UDI

Identifiers

Catalog Number
RF634 FDA UDI
Primary DI / UDI-DI
00842768037740 FDA UDI
510(k) Number
K162298 FDA UDI
FDA Product Code
MRG FDA UDI
GMDN Term
Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1825 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: Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

Dimension® EXL™ Total Vitamin D by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 1547e6ae-2ce8-4a9f-b71a-6e9e4c118748 37 fields · synced May 30, 2026