FDA.reportPublic FDA data

VITROS

Primary DI
10758750033300
Brand
VITROS
Company
ORTHO CLINICAL DIAGNOSTICS
Model
6192255
Catalog number
6192255
Device description
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
Published
2021-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K201312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201312000VITROS Immunodiagnostic Products NT-proBNP II Reagent PackOrtho Clinical Diagnostics2021-10-04NBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20758750033307PackageGS130In Commercial Distribution
10758750033300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075875003330720758750033307
1075875003330010758750033300

GMDN Terms#

Term, Definition table
TermDefinition
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials 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, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215865786
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10758750033287VITROS619773561977352020-05-16
10758750033294VITROS619557561955752020-05-16
10758750032891VITROS690004069000402025-12-30
10758750033522VITROS691223269122322025-12-30
10758750033539VITROS691223369122332025-12-30
10758750008322VITROS100940610094062020-04-08
10758750002061VITROS680215668021562015-12-22
10758750002504VITROS680230168023012015-12-22
10758750035366VITROS619945461994542025-05-20
10758750035373VITROS619945561994552025-05-20
10758750035380VITROS619945661994562025-05-20
20758750035363VITROS619945461994542025-05-20
20758750035370VITROS619945561994552025-05-20
20758750035387VITROS619945661994562025-05-20
10758750000203VITROS189683618968362016-08-26
10758750002801VITROS680245468024542014-10-22
10758750035465VITROS617444261744422023-11-22
10758750034420VITROS619996161999612021-11-08
10758750033355VITROS619991961999192021-03-22
10758750033362VITROS619992061999202021-03-22

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
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
00630414598024Atellica IM BNP QCSiemens Healthcare Diagnostics Inc.NBC2017-12-22
04015630939756Elecsys proBNP IIRoche Diagnostics GmbHNBC2017-04-21
00895160002434Fluoro-CheckTM NT-proBNPNANO-DITECH CORPORATIONNBC2016-10-05