Atellica CH UCFP Calibrator 11099339

GUDID 00630414285320

Atellica CH UCFP Calibrator

Siemens Healthcare Diagnostics Inc.

Total protein IVD, calibrator
Primary Device ID00630414285320
NIH Device Record Keye85f1ea1-1b47-4bbd-adda-f9053d97c9e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtellica CH UCFP Calibrator
Version Model Number11099339
Catalog Number11099339
Company DUNS064608573
Company NameSiemens Healthcare Diagnostics Inc.
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts


Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414279190 [Primary]
GS100630414285320 [Unit of Use]

FDA Product Code

JITCalibrator, secondary


Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-17
Device Publish Date2020-03-09

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

00630414294032 - Atellica IM BNP2020-06-08 BNP - Atellica IM - RGT 500T
00630414294049 - Atellica IM BR2020-06-08 BR CA27-29 - Atellica IM - RGT 250T
00630414294056 - Atellica IM BR Calibrator2020-06-08 BR Calibrator - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
00630414294278 - Atellica IM CA 125II2020-06-08 CA 125II Atellica IM - RGT 500T
00630414294063 - Atellica IM CA 15-32020-06-08 CA 15-3 Atellica IM - RGT 500T
00630414293516 - Atellica IM CA 19-92020-06-08 CA 19-9 Atellica IM - RGT 250T
00630414294070 - Atellica IM Calibrator 302020-06-08 Calibrator 30 - Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
00630414294087 - Atellica IM Calibrator A2020-06-08 Calibrator A - Atellica IM - CAL (6PK) 2 x 6 x 5.0 mL

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