FDA.reportPublic FDA data

Atellica CH A1c_3

Primary DI
00630414596129
Brand
Atellica CH A1c_3
Company
Siemens Healthcare Diagnostics Inc.
Model
11097500
Catalog number
11097500
Device description
Hemoglobin A1c_3 (A1c_3) Atellica CH - RGT 400T
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
LCPASSAY, GLYCOSYLATED HEMOGLOBIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCPAssay, Glycosylated HemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110934000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110934000ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAYSiemens Healthcare Diagnostics2011-08-25LCP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414596129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414596129006304145961296304145961290630414596129

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
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978139074008H100Plus HbA1c Eluent AShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074015H100Plus HbA1c Eluent AShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074022H100Plus HbA1c Eluent BShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074039H100Plus HbA1c Eluent CShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074046H100Plus HbA1c CalibratorShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074053H100Plus HbA1c Control MaterialShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074060H100Plus HbA1c Control MaterialShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074077H100Plus Hemolytic Agent LShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074084H100Plus Hemolytic Agent LShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074381H100Plus Hemoglobin Analyzer(HPLC)Shenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074398H100Plus Hemoglobin Chromatographic Column(HPLC)Shenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06978139074404H100Plus Hemoglobin Chromatographic Column(HPLC)Shenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
06980120080356H100Plus Hemolytic Agent LShenzhen Lifotronic Technology Co.,Ltd.LCP2026-11-03
00380740208622ARCHITECTAbbott GmbHLCP2026-05-15
00380740208639AlinityAbbott GmbHLCP2026-05-15
00860004423409QvinQurasense, Inc.LCP2026-05-08
00860004423492QvinQurasense, Inc.LCP2026-05-08
04562185405262GR01 HbA1c Elution Buffer No. 1TOSOH CORPORATIONLCP2026-01-05
04562185405279GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONLCP2026-01-05
04562185405286GR01 HbA1c Elution Buffer No. 3TOSOH CORPORATIONLCP2026-01-05
04562185400571HbA1c Diluting SolutionTOSOH CORPORATIONLCP2026-01-05
04562185404920Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01TOSOH CORPORATIONLCP2026-01-05
0456218540493790 Sample Loader TOSOH CORPORATIONLCP2026-01-05
04562185404944290 Sample LoaderTOSOH CORPORATIONLCP2026-01-05
04562185405255TSKgel GR01 HbA1c ColumnTOSOH CORPORATIONLCP2026-01-05
14562185405269GR01 HbA1c Elution Buffer No. 1TOSOH CORPORATIONLCP2026-01-05
14562185405276GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONLCP2026-01-05
14562185405283GR01 HbA1c Elution Buffer No. 3TOSOH CORPORATIONLCP2026-01-05
04562185406207Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 LATOSOH CORPORATIONLCP2026-01-05
04713106028187URIGHT Hemoglobin A1c AnalyzerTAIDOC TECHNOLOGY CORPORATIONLCP2025-03-26