FDA.reportPublic FDA data

Atellica IM Toxo M QC

Primary DI
00630414600154
Brand
Atellica IM Toxo M QC
Company
Siemens Healthcare Diagnostics Inc.
Model
10995702
Catalog number
10995702
Device description
Toxoplasma M IgM (ToxM) QC Kit Atellica IM - CLT 2 x 2 x 1.5mL
Published
2018-02-06
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
LGDENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma GondiiMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010755000BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAYBayer Corp.2001-08-20LGD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414600154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414600154006304146001546304146001540630414600154

GMDN Terms#

Term, Definition table
TermDefinition
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Upright, Do not freeze, Resuspend.
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
00380740189976AlinityAbbott GmbHLGD2025-04-08
00380740190002AlinityAbbott GmbHLGD2025-04-08
00380740200626AlinityAbbott GmbHLGD2025-04-08
00380740200633AlinityAbbott GmbHLGD2025-04-08
00816870024080Toxo IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LGD2024-09-13
00816870024097Toxo IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LGD2024-09-13
00816870024127Toxo IgM AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LGD2024-09-13
00816870024134Toxo IgM AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LGD2024-09-13
07613336218464Elecsys Toxo IgMRoche Diagnostics GmbHLGD2024-08-13
00850054026002QMedix™Diagnostic Automation, Inc.LGD2024-02-02
00850049545662AccuDiag ™Diagnostic Automation, Inc.LGD2023-06-14
B3507203000Gold Standard Diagnostics Is-Toxoplasma IgG ELISA Test KitGold Standard Diagnostics CorporationLGD2022-12-05
00380740174354AlinityAbbott GmbHLGD2022-11-26
00380740174361AlinityAbbott GmbHLGD2022-11-26
00380740203177AlinityAbbott GmbHLGD2022-11-26
05391516746823Trinity BiotechCLARK LABORATORIES, INC.LGD2019-12-26
05391516747479Trinity BiotechCLARK LABORATORIES, INC.LGD2019-12-26
00630414600123Atellica IM Toxo GSiemens Healthcare Diagnostics Inc.LGD2018-02-06
00630414600130Atellica IM Toxo G QCSiemens Healthcare Diagnostics Inc.LGD2018-02-06
00630414600147Atellica IM Toxo MSiemens Healthcare Diagnostics Inc.LGD2018-02-06
03610520150269BioPlex 2200BIO-RAD LABORATORIES, INC.LGD2017-08-05
03610521167488BioPlex 2200BIO-RAD LABORATORIES, INC.LGD2017-08-05
03610520992715BioPlex 2200BIO-RAD LABORATORIES, INC.LGD2017-08-05
04015630921485Elecsys Toxo IgMRoche Diagnostics GmbHLGD2017-07-31
04015630940318Elecsys Toxo IgMRoche Diagnostics GmbHLGD2017-07-31
04015630940301Elecsys Toxo IgGRoche Diagnostics GmbHLGD2017-04-21
00630414208442ADVIA Centaur® Toxo MSiemens Healthcare Diagnostics Inc.LGD2016-09-24
00630414208459ADVIA Centaur® Toxo GSiemens Healthcare Diagnostics Inc.LGD2016-09-24
00630414208756ADVIA Centaur® Toxo G QCSiemens Healthcare Diagnostics Inc.LGD2016-09-24
00630414208763ADVIA Centaur® Toxo M QCSiemens Healthcare Diagnostics Inc.LGD2016-09-24