FDA.reportPublic FDA data

BCS® System Cuvette Rotors

Primary DI
00842768014444
Brand
BCS® System Cuvette Rotors
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10446524
Catalog number
OVIP15
Device description
The BCS Cuvette Rotor is part of the BCS-XP system.
Published
2017-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00842768014444PrimaryGS10
00842768024603Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768014444008427680144448427680144440842768014444
00842768024603008427680246038427680246030842768024603

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius32 Degrees Celsius

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
126
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00842768017742Washing Solution for Coagulation Analyzers10446684OWZC392016-09-24
00842768024887BFT II Analyzer10458677OVKF0322016-09-24
00630414639703Control Plasma P10873891108738912024-02-19
00630414639772Standard Human Plasma10873907108739072024-03-25
00630414640167Dade Ci-Trol Coagulation Control Level 110873842108738422024-03-25
00630414640259Dade Ci-Trol Heparin Control, Low10873833108738332024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 210873843108738432024-03-25
00630414640365Dade Ci-Trol Heparin Control, High10873834108738342024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 310873844108738442024-03-25
00630414640747Control Plasma N 10873874108738742024-02-19
00842768003899Dade® Ci-Trol® Heparin Control, Low10445715B4224-502016-09-24
00842768003905Dade® Ci-Trol® Heparin Control, High10445716B4224-602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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