FDA.reportPublic FDA data

BCS® XP System

Primary DI
00630414945514
Brand
BCS® XP System
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10459330
Catalog number
OVOB03
Device description
The Behring Coagulation System (BCS XP System) performs quantitative assays of specific parameters in human citrated plasma
Published
2016-09-24
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
GKPINSTRUMENT, COAGULATION, AUTOMATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKPInstrument, Coagulation, AutomatedHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970431000BEHRING COAGULATION SYSTEMBehring Diagnostics, Inc.1997-05-05JPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414945514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414945514006304149455146304149455140630414945514

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation analyser IVD, laboratory, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection. 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)242-3233XX@XX.XX
+1(800)242-3233CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
1
Serial number
true

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
00195226000528ACL TOP 770INSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
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00195226000542ACL TOP 770sINSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
00195226000559ACL TOP 570INSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
00195226000566ACL TOP 370INSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
04987562516797CA CAL SSYSMEX CORPORATIONGKP2024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620SYSMEX CORPORATIONGKP2024-02-22
04987562518685Automated Blood Coagulation Analyzer CA-600 series CA-660SYSMEX CORPORATIONGKP2024-02-22
10850044118042iHealthIHEALTH LAB INC.GKP2022-09-30
10850044118059iHealthIHEALTH LAB INC.GKP2022-09-30
08426950452867HemosIL Reference EmulsionINSTRUMENTATION LABORATORY COMPANYGKP2020-04-09
08426950928027ACL TOP 300 CTSINSTRUMENTATION LABORATORY COMPANYGKP2018-05-28
00842768012198Behring Coagulation CupSiemens Healthcare Diagnostics Products GmbHGKP2017-10-31
00842768014444BCS® System Cuvette RotorsSiemens Healthcare Diagnostics Products GmbHGKP2017-10-31
04987562205936CA CAL SSYSMEX CORPORATIONGKP2017-10-06
00842768008023BC Validation KitSiemens Healthcare Diagnostics Products GmbHGKP2016-09-24
08426950003106HemosIL Sample DiluentINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950055990HemosIL Cleaning Solution (Clean A)INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950062295HemosIL Factor DiluentINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950075899Cuvettes (2400 cuvettes)INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950497059ACL AcuStar cuvettes (1400 pcs)INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950784074ACL TOP 750INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950784081ACL TOP 350 CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950927990ACL TOP 700INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950451600ACL TOP CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950453499ACL TOP 500 CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950497974ACL TOP 700INSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950497981ACL TOP 700 CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950497998ACL TOP 700 LASINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23
08426950556916ACL TOP 300 CTSINSTRUMENTATION LABORATORY COMPANYGKP2016-09-23