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ADVIA® Chemistry Enzyme 2 Calibrator

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
ADVIA® Chemistry Enzyme 2 Calibrator FDA UDI
Generic Name
Multiple clinical chemistry enzyme IVD, calibrator FDA UDI
Device Name
Enzyme 2 Calibrator - ADVIA Chemistry (ENZ 2 CAL) FDA UDI
Model / Reference
10916058 FDA UDI
Description
Enzyme 2 Calibrator - ADVIA Chemistry (ENZ 2 CAL) FDA UDI

Identifiers

Catalog Number
10916058 FDA UDI
Primary DI / UDI-DI
00630414008974 FDA UDI
FDA Product Code
JIX 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

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 clinical chemistry enzyme IVD, calibrator

ADVIA® Chemistry Enzyme 2 Calibrator 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 1519595e-cb68-411a-89cc-cbd39fc220cc 36 fields · synced Jun 8, 2026