FDA.reportPublic FDA data

Atellica IM BR MCM

Primary DI
00630414598062
Brand
Atellica IM BR MCM
Company
Siemens Healthcare Diagnostics Inc.
Model
10995479
Catalog number
10995479
Device description
BR CA27-29 Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Published
2017-12-27
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)
MOISYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
MOISystem, Test, Immunological, Antigen, TumorImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982680000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982680000CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAYChiron Diagnostics Corp.1998-10-15MOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414598062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598062006304145980626304145980620630414598062

GMDN Terms#

Term, Definition table
TermDefinition
Cancer antigen 27-29 (CA27-29) 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 cancer antigen 27-29 (CA27-29) 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

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