FDA.reportPublic FDA data

Atellica IM BNP QC

Primary DI
00630414598024
Brand
Atellica IM BNP QC
Company
Siemens Healthcare Diagnostics Inc.
Model
10995475
Catalog number
10995475
Device description
BNP QC Kit Atellica IM - CLT 3 x 3 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
NBCTEST,NATRIURETIC PEPTIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBCTest, Natriuretic PeptideClinical 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
00630414598024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414598024006304145980246304145980240630414598024

GMDN Terms#

Term, Definition table
TermDefinition
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide 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 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
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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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590786533Access BNP IIBeckman Coulter, Inc.NBC2026-03-30
05055845400596Alere NT-proBNP for Alinity Reagent Kit (200 Tests)AXIS-SHIELD DIAGNOSTICS LIMITEDNBC2025-02-26
15099590760823Access NT-proBNPBeckman Coulter, Inc.NBC2024-04-19
07613336217689Elecsys ProBNP IIRoche Diagnostics GmbHNBC2024-02-19
00630414284927ADVIA Centaur PBNPIISiemens Healthcare Diagnostics Inc.NBC2024-02-02
00630414284934ADVIA Centaur PBNPIISiemens Healthcare Diagnostics Inc.NBC2024-02-02
00630414284941Atellica IM PBNPIISiemens Healthcare Diagnostics Inc.NBC2024-02-02
00630414284958Atellica IM PBNPIISiemens Healthcare Diagnostics Inc.NBC2024-02-02
07613336191521Elecsys proBNP II ImmunoassayRoche Diagnostics GmbHNBC2022-05-07
07613336191569Elecsys proBNP II ImmunoassayRoche Diagnostics GmbHNBC2022-05-07
07613336191576Elecsys proBNP II STAT ImmunoassayRoche Diagnostics GmbHNBC2022-05-07
10758750033300VITROSORTHO CLINICAL DIAGNOSTICSNBC2021-11-08
15099590750947Access BNP Beckman Coulter, Inc.NBC2021-08-18
14560189212876ST AIA-PACK BNPTOSOH CORPORATIONNBC2021-01-01
04560189212879ST AIA-PACK BNPTOSOH CORPORATIONNBC2021-01-01
00630414293462Atellica IM BNPSiemens Healthcare Diagnostics Inc.NBC2020-05-31
00630414294032Atellica IM BNPSiemens Healthcare Diagnostics Inc.NBC2020-05-31
00380740145279ARCHITECTAbbott GmbHNBC2019-01-21
00380740145286ARCHITECTAbbott GmbHNBC2019-01-21
30014613337706TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613337959TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613337966TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613337973TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613337980TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613337997TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
30014613338031TriageQUIDEL CARDIOVASCULAR INC.NBC2018-11-01
00630414597980Atellica IM BNPSiemens Healthcare Diagnostics Inc.NBC2017-12-22
00630414597997Atellica IM BNPSiemens Healthcare Diagnostics Inc.NBC2017-12-22
04015630939756Elecsys proBNP IIRoche Diagnostics GmbHNBC2017-04-21
00895160002434Fluoro-CheckTM NT-proBNPNANO-DITECH CORPORATIONNBC2016-10-05