FDA.reportPublic FDA data

Atellica IM AFP MCM

Primary DI
00630414597720
Brand
Atellica IM AFP MCM
Company
Siemens Healthcare Diagnostics Inc.
Model
10995443
Catalog number
10995443
Device description
Alpha-Fetoprotein(AFP) - Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL
Published
2018-11-14
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)
LOKKIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
LOKKit, Test, Alpha-Fetoprotein For Neural Tube DefectsUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P930036001
P930036002
P930036003
P930036008
P930036009

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P930036001ADVIA CENTAUR AFP REAGENTS AND CALIBRATORSSiemens Healthcare Diagnostics, Inc.1995-09-29LOK
P930036002ADVIA CENTAUR AFP REAGENTS AND CALIBRATORSSiemens Healthcare Diagnostics, Inc.1995-09-29LOK
P930036003ADVIA CENTAUR AFP REAGENTS AND CALIBRATORSSiemens Healthcare Diagnostics, Inc.1995-09-29LOK
P930036008ADVIA CENTAUR AFP REAGENTS AND CALIBRATORSSiemens Healthcare Diagnostics, Inc.1995-09-29LOK
P930036009ADVIA CENTAUR AFP REAGENTS AND CALIBRATORSSiemens Healthcare Diagnostics, Inc.1995-09-29LOK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414597720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414597720006304145977206304145977200630414597720

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-fetoprotein (AFP) 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 alpha-fetoprotein (AFP) 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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