System, Multipurpose For In Vitro Coagulation Studies

Product Code: JPA

Hematology In Vitro And Other Medical Laser Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Laser Products. [1040.10]

Code of Federal Regulations: 864.5425


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as JPA

2362System, Multipurpose For In Vitro Coagulation StudiesMultipurpose System For In Vitro Coagulation Studies.

Total Product Life Cycle (TPLC) Devices

2362System, Multipurpose For In Vitro Coagulation StudiesMultipurpose System For In Vitro Coagulation Studies.

FDA Consensus Standards

System, Multipurpose For In Vitro Coagulation Studies [32368]21 CFR §864.5425 🔎
System, Multipurpose For In Vitro Coagulation Studies [21764]21 CFR §864.5425 🔎
System, Multipurpose For In Vitro Coagulation Studies [26729]21 CFR §864.5425 🔎
System, Multipurpose For In Vitro Coagulation Studies [32362]21 CFR §864.5425 🔎

Pre-market Notifications for JPA

K202101GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), DirectCHECK ACT+ Whole Blood Control, Level 1 And Level 2, DirectCHECK ACT-LR Whole Blood ControlAccriva Diagnostics, Inc.
K201440ROTEM Sigma Thromboelastometry SystemTem Innovations GmbH
K193041Hemochron Signature EliteAccriva Diagnostics, Inc.
K183390QNext And DG-PTDiagnostic Grifols, S.A.
K183160TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeHaemonetics Corporation
K173202CP3000 Coagulation Analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control SetSekisui Medical Co., Ltd.
K172333Sysmex CS-5100Siemens Healthcare Diagnostics Products GmbH
K172286Automated Blood Coagulation Analyzer CS-2500Siemens Healthcare Diagnostic Products Gmbh
K170314ACL AcuStarINSTRUMENTATION LABORATORY CO.
K162688Sysmex CS-2100iSiemens Healthcare Diagnostics Products GmbH
K162420Sysmex Automated Blood Coagulation Analyzer CS-5100SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
K161317Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH
K161312Sysmex Automated Blood Coagulation Analyzer CS-2100iSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
K160502TEG 6s Hemostasis SystemHaemonetics Corporation
K151867STA R MAXDIAGNOSTICA STAGO S.A.S.

Global Unique Device Identification Database

00613994615633SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
00673978519173SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
00842768026812SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
00842768024887SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
00842768017742SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
00842768014222SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
00842768012358SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
00842768012259SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
00842768006869SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
00842768006845SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
05391521421081System, Multipurpose For In Vitro Coagulation Studies
05391521421029System, Multipurpose For In Vitro Coagulation Studies
05391521421012System, Multipurpose For In Vitro Coagulation Studies
05391521421005System, Multipurpose For In Vitro Coagulation Studies
04987562433735SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Maude Adverse Events

CA-1500SYSMEX RA CO. LTD.2020-03-02
TEG? 5000 THROMBELASTOGRAPH? HEMOSTASIS ANALYZERHAEMONETICS CORPORATION2020-01-28
STA COMPACTDIAGNOSTICA STAGO2020-01-21
STA COMPACTDIAGNOSTICA STAGO2020-01-20
STA-R EVOLUTIONDIAGNOSTICA STAGO2020-01-16
STA-R EVOLUTIONDIAGNOSTICA STAGO2020-01-16
STA-R MAXDIAGNOSTICA STAGO2019-10-16
STA-R MAXDIAGNOSTICA STAGO S.A.S.2019-10-04
STA COMPACT MAXDIAGNOSTICA STAGO S.A.S2019-09-30
STA COMPACT MAXDIAGNOSTICA STAGO S.A.S.2019-09-13
SYSMEX CS-2100I AUTOMATED COAGULATION ANALYZERSYSMEX CORPORATION, I SQUARE2019-08-01
STA-R MAXDIAGNOSTICA STAGO S.A.S.2019-07-22
SIAGNOSTICA STAGO STA R MAXDIAGNOSTICA STAGO2019-07-08
STA R MAXDIAGNOSTICA STAGO S.A.S.2019-06-25
STA-R MAXDIAGNOSTICA STAGO S.A.S.2019-05-14
SYSMEX CS-2100ISYSMEX CORPORATION, I SQUARE2019-04-03
CS-2500SYSMEX CORPORATION, I SQUARE2019-03-28
STA-R EVOLUTIONDIAGNOSTICA STAGO S.A.S.2019-03-27
STA-R EVOLUTIONDIAGNOSTICA STAGO S.A.S.2019-03-20
STA COMPACT MAX PERCAGEDIAGNOSTICA STAGO S.A.S.2019-03-11
HEMOSIL ACUSTARINSTRUMENTATION LABORATORY2019-02-05
STA COMPACT MAXDIAGNOSTICA STAGO S.A.S2019-01-21
STAGO EVOLUTIONDIAGNOSTICA STAGO, INC.2019-01-17
EVOLUTIONDIAGNOSTICA STAGO GENNEVILLIERS2019-01-16
SYSMEX CS-2500SYSMEX CORPORATION, I SQUARE2019-01-10
HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEMACCRIVA DIAGNOSTICS2018-12-27
HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEMACCRIVA DIAGNOSTICS2018-12-27
HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEMACCRIVA DIAGNOSTICS2018-12-26
HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEMACCRIVA DIAGNOSTICS2018-12-20
HEMOCHRON SIGNATURE ELITEACCRIVA DIAGNOSTICS2018-11-28
HEMOCHRON SIGNATURE ELITE INTERNATIONALACCRIVA DIAGNOSICS2018-11-19
SYSMEX CA-1500SYSMEX RA CO., LTD. MAIN PLANT2018-11-16
STA R MAXDIAGNOSTICA STAGO - GENNEVILLIERS2018-10-30
STA R MAXDIAGNOSTICA STAGO - GENNEVILLIERS2018-10-30
HEMOCHRON SIGNATURE ELITE INTERNATIONALACCRIVA DIAGNOSTICS2018-10-22
HEMOCHRON SIGNATURE ELITEACCRIVA DIAGNOSTICS2018-10-22
HEMOCHRON SIGNATURE ELITEACCRIVA DIAGNOSTICS2018-09-26
HEMOCHRON RESPONSE INSTRUMENTACCRIVA DIAGNOSTICS2018-09-12
HEMOCHRON RESPONSE INSTRUMENTACCRIVA DIAGNOSTICS2018-09-12
HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEMACCRIVA DIAGNOSTICS2018-09-12
ROTEM DELTA SYSTEMTEM INNOVATIONS GMBH2018-08-31
STA-R EVOLUTIONDIAGNOSTICA STAGO S.A.S.2018-08-07
STA COMPACT MAXDIAGNOSTICA STAGO S.A.S.2018-07-31
HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEMACCRIVA DIAGNOSTICS2018-07-18
HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEMACCRIVA DIAGNOSTICS2018-07-18
HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEMACCRIVA DIAGNOSTICS2018-07-18
CA-560SYSMEX RA CO. LTD.2018-07-05
HEMOCHRON SIGNATURE ELITE MICROCOAGULATION SYSTEMACCRIVA DIAGNOSTICS2018-06-25
EX-TEM? REAGENTTEM INNOVATIONS GMBH2018-06-21
HEMOCHRON SIGNATURE ELITE WHOLE BLOOD MICROCOAGULATION SYSTEMACCRIVA DIAGNOSTICS2018-06-18
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