FDA.reportPublic FDA data

Atellica IM BNP Calibrator

Primary DI
00630414598000
Brand
Atellica IM BNP Calibrator
Company
Siemens Healthcare Diagnostics Inc.
Model
10995473
Catalog number
10995473
Device description
BNP - Atellica IM - CAL - (2 PK) 2 x 2 x 2.0 mL
Published
2017-12-22
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
JITCalibrator, secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031038000ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYBayer Healthcare, LLC2003-06-23NBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414598000PrimaryGS10
00630414190617Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598000006304145980006304145980000630414598000
00630414190617006304141906176304141906170630414190617

GMDN Terms#

Term, Definition table
TermDefinition
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of B-type natriuretic protein (BNP) and/or N-terminal pro b-type natriuretic peptide (NT-proBNP) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
2
Lot or batch
true
Expiration date on label
true

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