Atellica CH Urine Albumin (UAlb) 11537225

GUDID 00630414320298

Atellica CH Microalbumin (UAlb) Reagent

Siemens Healthcare Diagnostics Inc.

Albumin IVD, kit, nephelometry/turbidimetry
Primary Device ID00630414320298
NIH Device Record Key03b94cc5-02fe-4d4f-bc4a-6d7fdd52cadd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtellica CH Urine Albumin (UAlb)
Version Model Number11537225
Catalog Number11537225
Company DUNS064608573
Company NameSiemens Healthcare Diagnostics Inc.
Device Count4
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light and heat; Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light and heat; Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light and heat; Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light and heat; Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light and heat; Do not freeze
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414320298 [Unit of Use]
GS100630414611099 [Primary]

FDA Product Code

DCFALBUMIN, ANTIGEN, ANTISERUM, CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-19
Device Publish Date2025-08-11

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

00630414320298 - Atellica CH Urine Albumin (UAlb)2025-08-19Atellica CH Microalbumin (UAlb) Reagent
00630414320298 - Atellica CH Urine Albumin (UAlb)2025-08-19 Atellica CH Microalbumin (UAlb) Reagent
00630414320304 - Atellica CH UAlb CAL2025-08-19 Atellica CH Microalbumin (UAlb) Calibrator
00630414579108 - ADVIA Centaur ELF Quality Control2025-08-18 Enhanced Liver Fibrosis (ELF) QC Kit - ADVIA Centaur - CLT 3 x 3 x 2.0 mL
00630414598901 - Atellica IM Enhanced Liver Fibrosis Quality Control (ELF QC)2025-08-18 Enhanced Liver Fibrosis (ELF) QC Kit - Atellica IM - CLT 3 x 3 x 2.0 mL
00630414632926 - Atellica IM DHEAS2 100T KIT2025-03-28 Atellica IM DHEASII 100T KIT
00630414632940 - Atellica IM DHEAS2 MCM SET2025-03-28 Atellica IM DHEASII MCM SET
00630414321486 - Atellica IM DHEAS2 (REF) 500T2025-03-28 Atellica IM DHEAS2 (REF) 500T Atellica IM-REF Reagent (REF RGT)
00630414650579 - Atellica IM 1300 Analyzer2025-03-24 Recertified Atellica IM 1300 Analyzer

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