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Dimension® ENZ II CAL

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® ENZ II CAL FDA UDI
Generic Name
Multiple clinical chemistry enzyme IVD, calibrator FDA UDI
Device Name
Enzyme II Calibrator, 2x3x1.5mL FDA UDI
Model / Reference
10476170 FDA UDI
Description
Enzyme II Calibrator, 2x3x1.5mL FDA UDI

Identifiers

Catalog Number
DC143 FDA UDI
Primary DI / UDI-DI
00842768034329 FDA UDI
510(k) Number
K103836 FDA UDI
FDA Product Code
JIT FDA UDI
GMDN Term
Multiple clinical chemistry enzyme 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

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 clinical chemistry enzyme IVD, calibrator

Dimension® ENZ II CAL by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry enzyme IVD, calibrator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 55df53bd-6e9c-45d2-b59c-12eae7193d2a 37 fields · synced May 29, 2026