Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Antithrombin Iii Quantitation

FDA product code JBQ · 56 cleared devices

Class 2 Hematology

Regulation: 21 CFR 864.7060
Review panel: HE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-03-30 – 2025-03-28

JBQ 2025-03-28

INNOVANCE Antithrombin

Applicant Siemens Healthcare Diagnostic Products GmbH

K number K242952

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JBQ 2009-05-28

INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5

Applicant Siemens Healthcare Diagnostics

K number K081769

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JBQ 2007-02-23

HEMOSIL ANTITHROMBIN

Applicant Instrumentation Laboratory CO

K number K070301

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JBQ 2006-09-01

HEMOSIL LIQUID ANTITHROMBIN

Applicant Instrumentation Laboratory CO

K number K062431

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JBQ 2005-11-07

BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105

Applicant Hyphen Biomed

K number K043007

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JBQ 2004-01-02

HEMOSIL LIQUID ANTITHROMBIN XL

Applicant Instrumentation Laboratory CO

K number K033775

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JBQ 2003-04-28

CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50

Applicant Precision Biologic

K number K023991

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JBQ 2002-08-27

COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS

Applicant Instrumentation Laboratory CO

K number K022550

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JBQ 2002-08-07

COAMATIC AT-400

Applicant Instrumentation Laboratory CO

K number K022195

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JBQ 2000-06-23

IL TEST LIQUID ANTITHROMBIN

Applicant Instrumentation Laboratory CO

K number K994238

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JBQ 2000-04-26

K-ASSAY AT-III

Applicant Kamiya Biomedical Co.

K number K000361

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JBQ 1998-04-02

IL TEST ANTITHROMBIN

Applicant Instrumentation Laboratory CO

K number K980499

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JBQ 1997-12-24

IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT

Applicant Beckman Instruments, Inc.

K number K974110

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JBQ 1997-07-25

SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III

Applicant Sigma Diagnostics, Inc.

K number K972144

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JBQ 1996-08-14

SPECTROLYSE ANTITHROMBIN III (ANTI-XA)

Applicant Medical Diagnostic Technologies, Inc.

K number K960871

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JBQ 1996-01-23

COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY

Applicant Chromogenix AB

K number K952515

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JBQ 1995-11-13

CHROM Z CHROMOGENIC ASSAYS

Applicant Helena Laboratories

K number K951943

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JBQ 1995-04-07

AT-III CALIBRATOR

Applicant American Bioproducts Co.

K number K944279

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JBQ 1994-12-22

BIOMERIEUX HEMOLAB AT III

Applicant Biomerieux Vitek, Inc.

K number K934156

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JBQ 1994-05-17

ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY

Applicant Sigma Diagnostics, Inc.

K number K935308

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JBQ 1994-05-04

ANTITHROMBIN III CHROMOGENIC ASSAY

Applicant Baxter Diagnostics, Inc.

K number K936196

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JBQ 1994-05-02

COATEST(R) ANTITHROMBIN III, MODIFICATION

Applicant Kabi Pharmacia Hepar, Inc.

K number K931420

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JBQ 1992-01-03

COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY

Applicant Kabi Pharmacia, Inc.

K number K915083

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JBQ 1992-01-03

ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT

Applicant The Binding Site, Ltd.

K number K913667

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JBQ 1991-01-24

LIATEST(R) AT III TEST KIT

Applicant American Bioproducts Co.

K number K905110

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JBQ 1990-09-25

COACUTE ANTITHROMBIN CHROMOGENIC ASSAY

Applicant Kabi Diagnostica

K number K902393

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JBQ 1990-08-09

SPECTROLYSE ATIII KIT

Applicant Biopool AB

K number K902530

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JBQ 1990-08-06

BECKMAN ANTITHROMBIN III REAGENT KIT

Applicant Beckman Instruments, Inc.

K number K901977

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JBQ 1990-03-15

ORTHOKROME* ANTITHROMBIN

Applicant Ortho Diagnostic Systems, Inc.

K number K900400

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JBQ 1989-06-23

ACTICHROME ATIII KIT

Applicant American Diagnostic Corp.

K number K893608

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JBQ 1988-12-20

TURBOX ANTITHROMBIN III

Applicant Unipath , Ltd.

K number K884144

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JBQ 1988-11-23

BERICHROM(R) ANTITHROMBIN III

Applicant Behring Diagnostics, Inc.

K number K883662

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JBQ 1988-04-27

ENZYGNOST(R) TAT REAGENTS

Applicant Behring Diagnostics, Inc.

K number K880700

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JBQ 1988-03-16

DADE ANTITHROMBIN III CHROMOGENIC ASSAY

Applicant Baxter Healthcare Corp

K number K880315

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JBQ 1986-11-25

IL TEST 97574-15M, ANTITTHROMBIN III ASSASY

Applicant Instrumentation Laboratory CO

K number K864214

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JBQ 1985-05-08

GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY

Applicant Warner-Lambert Co.

K number K850412

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JBQ 1984-09-06

IL TEST ANTITHROMBIN III ACTIVITY

Applicant Instrumentation Laboratory CO

K number K841736

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JBQ 1983-09-29

DIACROM * ATIII

Applicant Wellcome Diagnostics

K number K832592

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JBQ 1983-08-12

RABBIT ANTI-HUMAN ANTITHROMBIN III

Applicant Gelco Diagnostics, Inc.

K number K832268

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JBQ 1983-08-11

IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN

Applicant Kent Laboratories, Inc.

K number K831961

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JBQ 1983-06-08

PROTOTRO/PROTEOLYTIC ENZYME CONTROL

Applicant American Dade

K number K831297

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JBQ 1981-12-30

COATEST ANTITHROMBIN

Applicant Kabivitrum, Inc.

K number K812829

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JBQ 1981-11-24

ACA ANTITHROMBIN III PLASMINOGEN CALIB

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K812626

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JBQ 1981-10-08

ACA ANTITHROMBIN III TEST PACK

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K812627

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JBQ 1981-09-01

ANTITHROMBIN III SCREEN KIT

Applicant Pacific Hemostasis

K number K812215

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JBQ 1980-12-22

HELENA AT-III QUIPLATE PROCEDURE

Applicant Helena Laboratories

K number K802912

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JBQ 1979-11-05

PHADECODE XA INHIBITOR ASSAY

Applicant Pharmaseal Div., Baxter Healthcare Corp.

K number K792019

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JBQ 1979-02-26

DETERMINATION OF ANTITHROMBIN III, 885

Applicant Sigma Chemical Co.

K number K790090

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JBQ 1978-12-04

ASSAY, CHROMOGENIC ANTITHROMBIN III

Applicant Ortho Diagnostics, Inc.

K number K781860

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JBQ 1978-11-08

ANTITHROMBIN III ASSAY

Applicant Dade, Baxter Travenol Diagnostics, Inc.

K number K781480

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JBQ 1978-08-10

ANTITHROMBIN III SERUM, ANTI-HUMAN

Applicant Icl Scientific

K number K781026

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JBQ 1978-02-03

LAS-R HUMAN ANTITHROMBIN III TEST

Applicant Hyland Therapeutic Div., Travenol Laboratories

K number K772328

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JBQ 1978-01-31

ANTITHROMBIN III ASSAY

Applicant Ortho Diagnostics, Inc.

K number K780002

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JBQ 1977-11-09

DIAG. KIT FOR TOTAL ANTITHROMBIN III

Applicant Abbott Laboratories

K number K771669

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JBQ 1977-07-21

PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY

Applicant Pharmaseal Div., Baxter Healthcare Corp.

K number K770942

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JBQ 1977-03-30

THROMBO-SCREEN AT-111 KIT

Applicant Bay Area Hema. Onco. Clinic. & Res. L

K number K770394

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