FDA.reportPublic FDA data

Atellica IM EPO

Primary DI
00630414245775
Brand
Atellica IM EPO
Company
Siemens Healthcare Diagnostics Inc.
Model
10733006
Catalog number
10733006
Device description
Erythropoietin (EPO) - Atellica IM - RGT 100T
Published
2019-11-18
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
GGTASSAY, ERYTHROPOIETIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGTAssay, ErythropoietinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183088000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183088000ADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics Limited2019-08-02GGT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414245775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414245775006304142457756304142457750630414245775

GMDN Terms#

Term, Definition table
TermDefinition
Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement of erythropoietin (EPO) in a clinical specimen, using a chemiluminescent immunoassay method.

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
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
04048474036466EPO (Erythropoietin) ELISADRG Instruments Gesellschaft mit beschränkter HaftungGGT2023-08-31
00083059070255EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.GGT2020-07-01
00630414010380ADVIA Centaur EPOSiemens Healthcare Diagnostics Inc.GGT2019-11-18
00840239036469EPO (Erythropoietin) ELISADRG International IncGGT2019-06-06
B24221EPOHUE010Erythropoietin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.GGT2017-08-03
08305900070255EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.GGT2016-12-07
15099590201838Access EPOBeckman Coulter, Inc.GGT2016-08-26
10815762021685Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.GGT2016-07-29
00815762021640Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.GGT2016-07-29
00815762021671Research and Diagnostic SystemsRESEARCH AND DIAGNOSTIC SYSTEMS, INC.GGT2016-07-29