← Back to catalogue

Atellica IM Calibrator D

FDA UDI

Class III (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Atellica IM Calibrator D FDA UDI
Generic Name
Multiple tissue-associated protein/tumour marker IVD, calibrator FDA UDI
Device Name
Calibrator D - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL FDA UDI
Model / Reference
10995509 FDA UDI
Description
Calibrator D - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL FDA UDI

Identifiers

Catalog Number
10995509 FDA UDI
Primary DI / UDI-DI
00630414598369 FDA UDI
PMA Number
P930036 FDA UDI
510(k) Number
K020806 FDA UDI
FDA Product Code
LOK FDA UDI
LOJ FDA UDI
GMDN Term
Multiple tissue-associated protein/tumour marker IVD, calibrator FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
866.6010 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 tissue-associated protein/tumour marker IVD, calibrator

Atellica IM Calibrator D by Siemens Healthcare Diagnostics — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple tissue-associated protein/tumour marker IVD, calibrator.

Cleared under the same submission

K020806 also covers:

P930036 also covers:

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 d3f4f915-d63a-4e4d-92ef-0ea4e1e2960b 37 fields · synced May 30, 2026