Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

FDA product code LFZ · 56 cleared devices

Class 2 Microbiology

Regulation: 21 CFR 866.3175
Review panel: MI
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1982-12-28 – 2022-10-27

LFZ 2022-10-27

Architect CMV IgG

Applicant Abbott Laboratories

K number K220949

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LFZ 2022-10-12

Elecsys CMV IgG

Applicant Roche Diagnostics

K number K220911

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LFZ 2018-07-30

ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control

Applicant Siemens Healthcare Diagnostics, Inc.

K number K181213

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LFZ 2017-03-17

Elecsys CMV IgM

Applicant Roche Diagnostics

K number K163569

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LFZ 2017-01-06

LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set

Applicant DiaSorin, Inc.

K number K162969

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LFZ 2005-06-01

DIASORIN LIAISON CMV IGM/IGG

Applicant Diasorin S.P.A

K number K040290

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LFZ 1999-12-16

IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6

Applicant Diagnostic Products Corp.

K number K993952

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LFZ 1999-01-13

SERAQUEST CMV IGM

Applicant Quest Intl., Inc.

K number K982485

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LFZ 1999-01-11

THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

Applicant Zeus Scientific, Inc.

K number K984139

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LFZ 1998-12-14

THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

Applicant Zeus Scientific, Inc.

K number K983803

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LFZ 1998-11-25

MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY

Applicant DiaSorin, Inc.

K number K982027

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LFZ 1998-09-21

DIAMEDIX IS-CMV IGG TEST SYSTEM

Applicant Diamedix Corp.

K number K981163

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LFZ 1997-12-01

QUANTA LITE CMV IGG ELISA

Applicant Inova Diagnostics, Inc.

K number K971335

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LFZ 1997-03-24

ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)

Applicant Abbott Laboratories

K number K954301

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LFZ 1997-02-20

HEMAGEN CMV IGG KIT

Applicant Hemagen Diagnostics, Inc.

K number K944438

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LFZ 1996-10-17

INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530

Applicant Incstar Corp.

K number K960434

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LFZ 1996-10-09

OPUS CMV TEST SYSTEM-MODIFICATION

Applicant Behring Diagnostics, Inc.

K number K963084

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LFZ 1996-09-20

AXSYM CMV IGG ANTIBODY ASSAY

Applicant Abbott Laboratories

K number K953943

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LFZ 1996-07-22

INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY

Applicant Incstar Corp.

K number K955361

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LFZ 1996-07-22

INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY

Applicant Incstar Corp.

K number K955360

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LFZ 1996-06-17

IMMULITE CMV IGG

Applicant Diagnostic Products Corp.

K number K950672

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LFZ 1996-02-23

SERAQUEST CMV IGG

Applicant Quest Intl., Inc.

K number K954191

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LFZ 1994-06-28

OPUS CMV-G

Applicant Pb Diagnostic Systems, Inc.

K number K933389

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LFZ 1993-04-08

BARTELS CYTOMEGALOVIRUS IGG EIA

Applicant Baxter Diagnostics, Inc.

K number K922582

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LFZ 1993-04-02

CMV ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K924096

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LFZ 1993-02-12

VIDAS CMV IGG ASSAY

Applicant Vitek Systems, Inc.

K number K920661

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LFZ 1992-07-27

PHARMACIA CMV IGM ELISA

Applicant Pharmacia Diagnostics, Inc.

K number K921011

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LFZ 1992-05-04

CAPTIA CMV-TA

Applicant Mercia Diagnostics , Ltd.

K number K915479

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LFZ 1992-04-28

ENZYGNOST(R) ANTI-CMV IGG

Applicant Behring Diagnostics, Inc.

K number K913910

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LFZ 1992-02-27

ENZYGNOST(R) ANTI-CMV/IGM

Applicant Behring Diagnostics, Inc.

K number K913693

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LFZ 1992-02-14

CMV IGG ELISA TEST

Applicant Gull Laboratories, Inc.

K number K915892

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LFZ 1991-05-20

ENZYGNOST ANTI-CMV/IGG + IGM

Applicant Behring Diagnostics, Inc.

K number K901485

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LFZ 1991-04-03

CYTOMEGALOVIRUS (CMV) ELISA

Applicant Virotech, Inc.

K number K904456

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LFZ 1990-12-17

ORTHO CMV-G ANTIBODY ELISA TEST

Applicant Ortho Diagnostic Systems, Inc.

K number K905078

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LFZ 1990-12-17

ORTHO CMV-M ANTIBODY ELISA TEST

Applicant Ortho Diagnostic Systems, Inc.

K number K905077

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LFZ 1990-12-17

CMV IGM ELISA TEST

Applicant Gull Laboratories, Inc.

K number K903807

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LFZ 1990-07-27

IMX CMV IGG ANTIBODY ASSAY

Applicant Abbott Laboratories

K number K900474

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LFZ 1990-07-27

IMX CMV IGM ANTIBODY ASSAY

Applicant Abbott Laboratories

K number K900473

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LFZ 1990-05-02

CMV IGG ELISA TEST

Applicant Gull Laboratories, Inc.

K number K900796

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LFZ 1990-03-06

CAPTIA(R) CMV-M

Applicant Mercia Diagnostics , Ltd.

K number K896295

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LFZ 1990-03-06

CAPTIA(R) CMV-G

Applicant Mercia Diagnostics , Ltd.

K number K896194

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LFZ 1990-02-27

CMV IGM ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K896355

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LFZ 1989-12-18

DETECTADOT TM SYSTEM 2000 CMV IGM TEST

Applicant Gull Laboratories, Inc.

K number K893230

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LFZ 1989-06-23

ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT

Applicant Orgenics, Ltd.

K number K891393

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LFZ 1989-06-23

VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM

Applicant Organon Teknika Corp.

K number K890610

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LFZ 1989-06-02

CMV ELISA TEST SYSTEM

Applicant Zeus Scientific, Inc.

K number K891081

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LFZ 1989-04-11

CMV-CUBE(TM)

Applicant Difco Laboratories, Inc.

K number K884842

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LFZ 1989-04-10

MODIFIED DDI SEROCARD CMV IGG TEST KIT

Applicant Disease Detection International, Inc.

K number K884248

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LFZ 1989-03-27

UBI MAGIWEL CMV IGG QUANTITATIVE

Applicant United Biotech, Inc.

K number K883399

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LFZ 1989-03-27

CYTOMEGALOVIRUS IGG EIA KIT

Applicant De Ferris Laboratories, Inc.

K number K880433

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LFZ 1988-05-13

SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT

Applicant Disease Detection International, Inc.

K number K875361

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LFZ 1985-09-16

ENZYGNOST + ANTI-CMV IGG TEST

Applicant Behring Diagnostics, Inc.

K number K852478

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LFZ 1983-10-27

YBBOTT CMV TOTAL AB EIA

Applicant Abbott Laboratories

K number K832221

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LFZ 1983-08-08

CMV RQ BIO-ENZABEAD KIT

Applicant Litton Bionetics

K number K831343

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LFZ 1983-05-09

CYTOMEGELISA STAT

Applicant M.A. Bioproducts

K number K830615

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LFZ 1982-12-28

CORDIA CMV

Applicant Cordis Corp.

K number K823123

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