FDA.reportPublic FDA data

Atellica CH AAT

Primary DI
00630414596228
Brand
Atellica CH AAT
Company
Siemens Healthcare Diagnostics Inc.
Model
11097628
Catalog number
11097628
Device description
Alpha-1-Acid-Antitrypsin (AAT) Atellica CH RGT 360T
Published
2017-12-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DEMALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DEMAlpha-1-Antitrypsin, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031857000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031857000ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAYBayer Diagnostics Corp.2003-09-04DEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414596228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414596228006304145962286304145962280630414596228

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of alpha-1-antitrypsin (protease inhibitor) in a clinical specimen, using a nephelometry/turbidimetry method. Alpha-1-antitrypsin deficiency is typically associated with liver cirrhosis and pulmonary emphysema.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)11538186115381862026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)11538187115381872026-05-29
00630414517681ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents1031820830554832020-09-24
00842768016912Dimension® PBNP Calibrator10445008RC423A2016-09-24
00630414498942ADVIA® Chemistry ACET Acetaminophen Reagents1032738179891382016-09-24
00630414568768ADVIA® Chemistry BENZ_2 Benzodiazepine_2 Reagents10378760103787602016-09-24
00630414611075Atellica CH Crea311537215115372152026-05-08
00630414653259Atellica CH Crea311537567115375672026-05-08
00630414618456ADVIA CENTAUR ELF MCM SET11208709112087092023-03-15
00630414506005ADVIA® Chemistry HAPT Haptoglobin Reagents103141648310082016-09-24
00630414595795Atellica CH ECre_211097533110975332017-12-22
00842768015281Dimension Vista® Flex® reagent cartridge LIDO10445132K41132016-09-24
00630414291338ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)11354590113545902026-04-16
00630414291345Atellica IM CYFRA 21-111354591113545912026-04-16
00630414292779Siemens Healthineers CYFRA 21-1 MCM11536187115361872026-04-16
00630414292786Atellica IM CYFRA 21-1 MCM11536188115361882026-04-16
00630414611693ADVIA Centaur Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL)11553956115539562026-04-16
00630414622804Atellica IM CYFRA21-1 Calibrator11553957115539572026-04-16
00630414654041Atellica CH Ca11645759116457592026-04-08
00630414654102Atellica CH ALP_2c11645758116457582026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051700010696Human Alpha 1 Antitrypsin NL BINDARID™ KitTHE BINDING SITE GROUP LIMITEDDEM2023-06-29
07613336130230Tina-quant a1-Antitrypsin ver.2Roche Diagnostics GmbHDEM2020-03-05
00380740156299ARCHITECTABBOTT LABORATORIESDEM2020-03-03
00380740156374ARCHITECTABBOTT LABORATORIESDEM2020-03-03
00380740156411ARCHITECTABBOTT LABORATORIESDEM2020-03-03
00380740153519AlinityABBOTT LABORATORIESDEM2019-01-04
00817302023152CLC720 Chemistry Analyzer w/ISECAROLINA LIQUID CHEMISTRIES CORPORATIONDEM2016-12-19
15099590010607AUBECKMAN COULTER IRELAND INC.DEM2016-09-24
B1761220Antiserum to Alpha 1 AntitrypsinKENT LABORATORIES INCDEM2016-09-24
05051700016421Human alpha 1 antitrypsin Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDEM2016-09-24
05051700017763Optilite Alpha-1-antitrypsin KitTHE BINDING SITE GROUP LIMITEDDEM2016-09-24
00842768005992Dimension Vista®a1-Antitrypsin Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDEM2016-09-24
00842768009921N Antiserum to Human a1-AntitrypsinSiemens Healthcare Diagnostics Products GmbHDEM2016-09-24
00842768009938N Antiserum to Human a1-AntitrypsinSiemens Healthcare Diagnostics Products GmbHDEM2016-09-24
00630414517728ADVIA® Chemistry AAT Alpha-1-Antitrypsin ReagentsSiemens Healthcare Diagnostics Inc.DEM2016-09-24
04015630916597Tinaquant 1Antitrypsin ver2Roche Diagnostics GmbHDEM2016-09-20
04015630928415Tinaquant 1Antitrypsin ver2Roche Diagnostics GmbHDEM2016-09-20
04015630927562Albumin BCPRoche Diagnostics GmbHDEM2016-09-20
04015630906758Tina-quant alpha1-AntitrypsinRoche Diagnostics GmbHDEM2016-09-20
00816426020009K-ASSAY® Alpha-1 AT ReagentKAMIYA BIOMEDICAL COMPANY, LLCDEM2016-09-16
00380740030131ARCHITECTABBOTT LABORATORIESDEM2016-09-09
00380740044862ARCHITECTABBOTT LABORATORIESDEM2016-09-09
00380740054151ARCHITECTABBOTT LABORATORIESDEM2016-09-09
15099590224042IMMAGEBeckman Coulter, Inc.DEM2016-08-24
10758750002290VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DEM2016-08-23