FDA.reportPublic FDA data

Atellica IM IRI DIL

Primary DI
00630414600468
Brand
Atellica IM IRI DIL
Company
Siemens Healthcare Diagnostics Inc.
Model
10995630
Catalog number
10995630
Device description
Insulin (IRI) Diluent Atellica IM - CONS (2PK) 2 x 10mL
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CFPRADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFPRadioimmunoassay, Immunoreactive InsulinClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414600468PrimaryGS10
00630414007953Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414600468006304146004686304146004680630414600468
00630414007953006304140079536304140079530630414007953

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVD, automated/semi-automated systemA buffered diluent solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument during the processing, staining and/or testing of clinical laboratory specimens. Some types may, in addition be used for manual procedures.

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
2
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
00850049545723AccuDiag™ Insulin ELISADiagnostic Automation, Inc.CFP2026-01-27
00859410006269SalimetricsSALIMETRICS, LLCCFP2024-09-18
00859410006276SalimetricsSALIMETRICS, LLCCFP2024-09-18
04048474053616InsulinDRG Instruments Gesellschaft mit beschränkter HaftungCFP2023-09-01
04048474036084Anti-Insulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFP2023-08-31
04048474029352Insulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFP2023-08-29
00840239053619InsulinDRG International IncCFP2023-08-26
00840239036087Anti-Insulin ELISADRG International IncCFP2023-08-25
00840239029355Insulin ELISADRG International IncCFP2023-08-24
06925912718871iFlash-InsulinShenzhen YHLO Biotech Co., Ltd.CFP2022-10-26
00404847429350Insulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFP2021-06-07
00404847436082Anti-Insulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCFP2021-06-07
00404847453614InsulinDRG Instruments Gesellschaft mit beschränkter HaftungCFP2021-06-07
B24280INSHUCH100STELLUX® Chemi Human Insulin ELISA JumboAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
B24280INSHUE010ALPCO Insulin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
B24280INSHUE100ALPCO Insulin ELISA JumboAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
B24280INSHUUE010ALPCO Ultrasensitive Insulin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
B24280INSHUUE100ALPCO Ultrasensitive Insulin ELISA JumboAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-09-25
00630414461021ADVIA Centaur® IRISiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414466187ADVIA Centaur® IRI DILSiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414466200ADVIA Centaur® IRISiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414600444Atellica IM IRISiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414600475Atellica IM IRI DILSiemens Healthcare Diagnostics Inc.CFP2020-09-24
00630414954028IMMULITE®/IMMULITE® Systems 1000 Systems INS Insulin Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
00630414966014IMMULITE® 2000 Systems INS InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
00630414966045IMMULITE® 2000 Systems INS InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
00630414966243IMMULITE®/IMMULITE® 1000 Systems INS InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
00630414998954IMMULITE® INS Control InsulinSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCFP2020-09-24
B24280INSHUCH010STELLUX® Chemi Human Insulin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.CFP2020-07-17
00630414293691Atellica IM IRISiemens Healthcare Diagnostics Inc.CFP2020-05-31