FDA.reportPublic FDA data

ADVIA Centaur® aCCP IgG MCM

Primary DI
00630414592305
Brand
ADVIA Centaur® aCCP IgG MCM
Company
Siemens Healthcare Diagnostics Inc.
Model
10699140
Catalog number
10699140
Device description
Anti-CCP IgG (aCCP) MCM
Published
2019-04-05
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
JJXSINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153551000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153551000ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.Axis-Shield Diagnostics Limited2016-08-04NHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414592305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414592305006304145923056304145923050630414592305

GMDN Terms#

Term, Definition table
TermDefinition
Cyclic citrullinated peptide antibody (anti-CCP) 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 antibodies to cyclic citrullinated peptide (CCP) in a clinical specimen.

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

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