FDA.reportPublic FDA data

BN ProSpec® System

Primary DI
00630414002736
Brand
BN ProSpec® System
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10465217
Catalog number
OVLI012
Device description
The BN ProSpec® is a system for the quantitative determination of proteins in serum, plasma, urine and CSF
Published
2020-09-24
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
JZWNEPHELOMETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZWNephelometerImmunology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001647000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001647000BN PROSPEC SYSTEMDade Behring, Inc.2000-09-26JZW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414002736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414002736006304140027366304140027360630414002736

GMDN Terms#

Term, Definition table
TermDefinition
Nephelometry immunoassay analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen using an immunological method which utilizes a nephelometric detection system to determine the rate and/or quantity of particle agglutination occurring through the formation of immune complexes, together with sample processing, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)664-3822XX@XX.XX
+1(800)664-3822CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414634029INNOVANCE D-Dimer 2.010873803108738032026-08-19
00630414634210INNOVANCE D-Dimer 2.0 Diluent10873807108738072026-08-19
00630414634234INNOVANCE D-Dimer 2.0 Control 310873806108738062026-08-19
00630414634241INNOVANCE D-Dimer 2.0 Control 210873805108738052026-08-19
00630414634258INNOVANCE D-Dimer 2.0 Control 110873804108738042026-08-19
00630414655949INNOVANCE D-Dimer 2.0 CONTROL 110874091108740912026-08-19
00630414656014INNOVANCE D-Dimer 2.010874090108740902026-08-19
00630414656021INNOVANCE D-Dimer 2.0 CONTROL 210874092108740922026-08-19
00630414656038INNOVANCE D-Dimer 2.0 CONTROL 310874093108740932026-08-19
00630414656069INNOVANCE D-Dimer 2.0 DILUENT10874094108740942026-08-19
00630414312446N FLC Supplementary Reagent10873769108737692026-06-26
00630414285054N Latex ADNase B (USA)10873691108736912020-07-07
00842768013317N Latex ADNase B10446658OWTI112020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridge10445906K70642020-09-24
00842768012167N Cuvette Segments for BN II10446520OVIB312017-11-15
00842768012198Behring Coagulation Cup10446526OVIS312017-10-31
00842768012297N Evaporation Caps for Control Vials (2.5 mL)10446534OVLC212017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)10446535OVLC312017-10-31
00842768013065Enzygnost® TAT micro10446632OWMG152016-09-24
00842768014246N Reaction Buffer10446455OUMS652016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936895301660BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZW2023-07-05
00842768007781BN II AdditiveSiemens Healthcare Diagnostics Products GmbHJZW2020-09-24
00842768008153Cleaner SCSSiemens Healthcare Diagnostics Products GmbHJZW2020-09-24
00842768012297N Evaporation Caps for Control Vials (2.5 mL)Siemens Healthcare Diagnostics Products GmbHJZW2017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)Siemens Healthcare Diagnostics Products GmbHJZW2017-10-31
00842768012334N Cuvette Segments for BN ProSpec®Siemens Healthcare Diagnostics Products GmbHJZW2017-10-31