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Dimension® ALDL Calibrator

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® ALDL Calibrator FDA UDI
Generic Name
Low density lipoprotein (LDL) cholesterol IVD, calibrator FDA UDI
Device Name
ALDL Calibrator, 2x3x2ml FDA UDI
Model / Reference
10444996 FDA UDI
Description
ALDL Calibrator, 2x3x2ml FDA UDI

Identifiers

Catalog Number
DC131 FDA UDI
Primary DI / UDI-DI
00842768014093 FDA UDI
510(k) Number
K020723 FDA UDI
FDA Product Code
JIT FDA UDI
GMDN Term
Low density lipoprotein (LDL) cholesterol 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

Yes

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: Low density lipoprotein (LDL) cholesterol IVD, calibrator

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

Similar devices

Also classified as Low density lipoprotein (LDL) cholesterol 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 44023af4-a25b-4c32-99d7-06719c9fec91 37 fields · synced May 31, 2026