Atellica CH ENZ 3 Calibrator

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Atellica CH ENZ 3 Calibrator FDA UDI
Generic Name: Total creatine kinase (CK) IVD, calibrator FDA UDI
Device Name: Enzyme 3 (ENZ 3) Calibrator Atellica CH - CAL 6 x 2.0mL FDA UDI
Model / Reference: 11099319 FDA UDI
Description: Enzyme 3 (ENZ 3) Calibrator Atellica CH - CAL 6 x 2.0mL FDA UDI

Identifiers

Catalog Number: 11099319 FDA UDI
Primary DI / UDI-DI: 00630414597249 FDA UDI
510(k) Number: K160724 FDA UDI
FDA Product Code: JIT FDA UDI
GMDN Term: Total creatine kinase (CK) 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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: Total creatine kinase (CK) IVD, calibrator

Atellica CH ENZ 3 Calibrator by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total creatine kinase (CK) IVD, calibrator.

JAS Diagnostics — Drew Scientific , Ltd. · Class II
JAS Diagnostics — Drew Scientific , Ltd. · Class II
JAS Diagnostics — Drew Scientific , Ltd. · Class II
JAS Diagnostics — Drew Scientific , Ltd. · Class II
ADVIA® Chemistry Enzyme 3 Calibrator — Siemens Healthcare Diagnostics · Class II

Cleared under the same submission

K160724 also covers:

Atellica CH CK_L — Siemens Healthcare Diagnostics

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

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

Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI f8b97c0e-ffc9-4ec3-baae-dbe804930660 37 fields · synced May 31, 2026