FDA.reportPublic FDA data

ADVIA Centaur® Toxo M QC

Primary DI
00630414208763
Brand
ADVIA Centaur® Toxo M QC
Company
Siemens Healthcare Diagnostics Inc.
Model
10310326
Catalog number
120383
Device description
TOXO IgM - CENTAUR - CONS - 2x2x1,5mL
Published
2016-09-24
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
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
00630414208763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414208763006304142087636304142087630630414208763

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, Protect from Light, 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

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