FDA.reportPublic FDA data

Atellica IM Fol

Primary DI
00630414293653
Brand
Atellica IM Fol
Company
Siemens Healthcare Diagnostics Inc.
Model
11206252
Catalog number
11206252
Device description
Folic Acid (Fol) - Atellica IM - RGT 700T
Published
2020-05-31
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
CGNACID, FOLIC, RADIOIMMUNOASSAY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGNAcid, Folic, RadioimmunoassayClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172201000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172201000Atellica IM Folate AssaySiemens Healthcare Diagnostics, Inc.2018-04-12CGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414293653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414293653006304142936536304142936530630414293653

GMDN Terms#

Term, Definition table
TermDefinition
Folate (vitamin B9) IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of folate (vitamin B9) 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
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00630414654133Atellica CH UA11645765116457652026-04-08
00630414293622Atellica IM DHEAS11206197112061972020-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740136567AlinityABBOTT IRELANDCGN2019-02-12
00816870020327Folate AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CGN2019-02-11
00816870020334Monobind AccuBind Folate ELISA Kit - 192 WellsMONOBIND, INC.CGN2019-02-11
00816870022000Folate AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CGN2019-02-11
00816870022017Folate AccuLite CLIA Test System -192 WellsMONOBIND, INC.CGN2019-02-11
00630414469454ADVIA Centaur® FOL (25-pack)Siemens Healthcare Diagnostics Inc.CGN2018-12-01
00380740130923AlinityABBOTT IRELANDCGN2018-11-12
00380740136550AlinityABBOTT IRELANDCGN2018-11-12
00630414597690Atellica™ IM RBC FOLSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414598963Atellica™ IM FolSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414598970Atellica™ IM FolSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414598987Atellica™ IM Fol DILSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414598994Atellica™ IM Fol MCMSiemens Healthcare Diagnostics Inc.CGN2018-06-05
00630414599007Atellica™ IM Fol DTT/Releasing AgentSiemens Healthcare Diagnostics Inc.CGN2018-06-05
04015630939695Elecsys FolateRoche Diagnostics GmbHCGN2017-04-21
00817830022597SimulTRAC-SNB Vitamin B12/Folate 125I RIA KitMP BIOMEDICALS, LLCCGN2017-01-09
00817830022603SimulTRAC-S Vitamin B12/Folate 125I RIA KitMP BIOMEDICALS, LLCCGN2017-01-09
00817830022542SimulTRAC-S Vitamin B12/Folate 125I RIA KitMP BIOMEDICALS, LLCCGN2016-10-20
14560189211916AIA-PACK FolateTOSOH CORPORATIONCGN2016-09-24
14560189212005AIA-PACK RBC FOLATETOSOH CORPORATIONCGN2016-09-24
04560189211926AIA-PACK Folate Calibrator SetTOSOH CORPORATIONCGN2016-09-24
04560189211933AIA-PACK Folate Pretreatment SetTOSOH CORPORATIONCGN2016-09-24
04560189211940AIA-PACK Floate Sample Diluting SolutionTOSOH CORPORATIONCGN2016-09-24
04560189212015AIA-PACK RBC FOLATE CALIBRATOR SETTOSOH CORPORATIONCGN2016-09-24
04560189212022AIA-PACK RBC FOLATE HEMOLYZING REAGENT SETTOSOH CORPORATIONCGN2016-09-24
04560189212039AIA-PACK RBC FOLATE PRETREATMENT SETTOSOH CORPORATIONCGN2016-09-24
04560189212046AIA-PACK RBC FOLATE SAMPLE DILUTING SOLUTIONTOSOH CORPORATIONCGN2016-09-24
00842768016653Dimension Vista® Flex® reagent cartridge FOLSiemens Healthcare Diagnostics Inc.CGN2016-09-24
00630414204192ADVIA Centaur® FOLSiemens Healthcare Diagnostics Inc.CGN2016-09-24
00630414208671ADVIA Centaur® FOL MCMSiemens Healthcare Diagnostics Inc.CGN2016-09-24