FDA.reportPublic FDA data

CA CAL S

Primary DI
04987562516797
Brand
CA CAL S
Company
SYSMEX CORPORATION
Model
014-1271-4
Device description
The product is applied to calibrate the sensitivity of LEDs used for blood coagulation analyzer.
Published
2024-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKPINSTRUMENT, COAGULATION, AUTOMATED

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987562516797PrimaryGS10
14987562516794Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987562516797049875625167974987562516797
1498756251679414987562516794

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation marker IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of multiple makers associated with coagulation including coagulation factors, intermediates and/or their activated components, functional tests [activated partial thromboplastin time (APTT), thrombin time (TT), prothrombin time (PT)] and/or physiological anticoagulants (e.g., antithrombin III) in a clinical specimen.

Contacts#

Phone, Email table
PhoneEmail
+1(888)879-7639crc@sysmex.com

Regulatory Flags#

DUNS number
690664461
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987562205936CA CAL S014127142017-10-06
00664369000899LYSERCELL WDF IICY754019ZA9000142026-04-24
04987562408528UF II CONTROL064041152022-11-30
04987562499700Automated Blood Coagulation Analyzer CN-3000CL971029CL9710292025-12-19
04987562518616Automated Blood Coagulation Analyzer CN-3000BN343315CL9710292025-12-19
14987562460264EIGHTCHECK-3WP140-3004-02016-08-05
14987562460387RANGE CHECK X lll2189812016-08-05
14987562460608plt-CHECK200-4004-02017-10-06
14987562460615plt-CHECK200-4004-12017-10-06
04987562518654Automated Blood Coagulation Analyzer CS-5100CU624138BY9907572024-02-22
04987562518661Automated Blood Coagulation Analyzer CS-2500AG528355BV9817982024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620CM217273BR1426262024-02-22
04987562518685Automated Blood Coagulation Analyzer CA-600 series CA-660CA174898CK9782892024-02-22
04987562425426Automated Blood Coagulation Analyzer CS-5100BY990757BY9907572016-08-05
04987562425686Automated Blood Coagulation Analyzer CA-600 series CA-620BR142626BR1426262016-08-04
04987562425716Automated Blood Coagulation Analyzer CA-600 series CA-660CK978289CK9782892016-08-05
04987562433735Automated Blood Coagulation Analyzer CS-2500BV981798BV9817982016-09-16
04987562499687Automated Blood Coagulation Analyzer CN-6000CV339763CV3397632025-08-22
04987562518630Automated Blood Coagulation Analyzer CN-6000AX801645CV3397632025-08-22
04987562488506UDM (Urinalysis Data Manager)1.XAB3645032025-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195226000528ACL TOP 770INSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
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00195226000559ACL TOP 570INSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
00195226000566ACL TOP 370INSTRUMENTATION LABORATORY COMPANYGKP2024-05-15
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
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08426950928027ACL TOP 300 CTSINSTRUMENTATION LABORATORY COMPANYGKP2018-05-28
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00842768008023BC Validation KitSiemens Healthcare Diagnostics Products GmbHGKP2016-09-24
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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