FDA.reportPublic FDA data

Atellica IM Fer

Primary DI
00630414294162
Brand
Atellica IM Fer
Company
Siemens Healthcare Diagnostics Inc.
Model
11206251
Catalog number
11206251
Device description
Ferritin (Fer) Atellica IM - RGT 450T
Published
2020-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DBFFERRITIN, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBFFerritin, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171642000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171642000Atellica IM Ferritin AssaySiemens Healthcare Diagnostics, Inc.2017-08-31DBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414293646PrimaryGS10
00630414294162Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414293646006304142936466304142936460630414293646
00630414294162006304142941626304142941620630414294162

GMDN Terms#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store upright, Protect from light
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
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00630414293646Atellica IM FerSiemens Healthcare Diagnostics Inc.DBF2020-05-31
03610230007327Yumizen C1200 FerritinHORIBA ABX SASDBF2020-05-06
07613336121238Tina-quant Ferritin Gen.4Roche Diagnostics GmbHDBF2020-03-05
00380740156275ARCHITECTABBOTT LABORATORIESDBF2020-03-03
00380740156329ARCHITECTABBOTT LABORATORIESDBF2020-03-03
00850392007251BioCheck Human Ferritin EIA Test KitBIOCHECK, INC.DBF2019-10-08
04560189212251AIA-PACK FER Calibration Verification Test SetTOSOH CORPORATIONDBF2019-07-25
14560189212258AIA-PACK FER Calibration Verification Test SetTOSOH CORPORATIONDBF2019-07-25
08600000686017Spectro Ferritin MTRamco Laboratories, Inc.DBF2019-03-23
00840239018724Ferritin ELISADRG International IncDBF2019-03-20
00380740131470AlinityABBOTT IRELANDDBF2018-07-31
00380740131487AlinityABBOTT IRELANDDBF2018-07-31
00630414598925Atellica IM FerSiemens Healthcare Diagnostics Inc.DBF2018-02-06
00630414598932Atellica IM FerSiemens Healthcare Diagnostics Inc.DBF2018-02-06
B24225FERHUE010Ferritin ELISAAMERICAN LABORATORY PRODUCTS COMPANY, LTD.DBF2017-08-03
14560189210483ST AIA-PACK FERTOSOH CORPORATIONDBF2016-09-24
15099590011901AUBeckman Coulter, Inc.DBF2016-09-24
B1761380Antiserum to Human FerritinKENT LABORATORIES INCDBF2016-09-24
04560189211452AIA-PACK FER Sample Diluting SolutionTOSOH CORPORATIONDBF2016-09-24
04560189211469ST AIA-PACK FER Calibrator SetTOSOH CORPORATIONDBF2016-09-24
05055273203073FERRRANDOX LABORATORIES LIMITEDDBF2016-09-24
05055273203080FERRRANDOX LABORATORIES LIMITEDDBF2016-09-24
05055273203097FERRRANDOX LABORATORIES LIMITEDDBF2016-09-24
00842768008085N Latex FerritinSiemens Healthcare Diagnostics Products GmbHDBF2016-09-24
00842768015182Dimension Vista® Flex® reagent cartridge FERRSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00857969006167ACEALFA WASSERMANN, INC.DBF2016-09-24
00630414177144ADVIA Centaur® FERSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00630414177151ADVIA Centaur® FERSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00630414204703ADVIA Centaur® FERSiemens Healthcare Diagnostics Inc.DBF2016-09-24
00630414586069ADVIA® Chemistry FRT Ferritin ReagentsSiemens Healthcare Diagnostics Inc.DBF2016-09-24