Radioimmunoassay, Vancomycin

FDA product code LEH · 31 cleared devices

Class 2 Clinical Toxicology

Regulation: 21 CFR 862.3950
Review panel: TX
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1981-12-08 – 2023-08-08

LEH 2023-08-08

Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K222439

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LEH 2016-04-27

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

Applicant Siemens Healthcare Diagnostics, Inc.

K number K160202

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LEH 2016-01-08

ONLINE TDM Vancomycin Gen.3

Applicant Roche Diagnostics Operations (Rdo)

K number K152245

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LEH 2013-08-29

ARCHITECT IVANCOMYCIN

Applicant Biokit, S.A.

K number K123947

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LEH 2008-03-19

ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01

Applicant Biokit, S.A.

K number K072036

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LEH 2006-12-05

IMMULITE 2000, IMMULITE 2500 VANCOMYCIN

Applicant Diagnostic Products Corp.

K number K063045

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LEH 2006-05-11

ENZYME IMMUNOASSAY, VANCOMYCIN

Applicant Roche Diagnostics Corp.

K number K060586

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LEH 2005-04-01

QMS VANCOMYCIN

Applicant Seradyn, Inc.

K number K050419

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LEH 2005-02-07

VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III

Applicant Ortho-Clinical Diagnostics, Inc.

K number K043386

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LEH 2003-11-24

CEDIA VANCOMYCIN ASSAY

Applicant Microgenics Corp.

K number K032811

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LEH 2002-05-10

EMIT 2000 VANCOMYCIN ASSAY

Applicant Dade Behring, Inc.

K number K020692

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LEH 2001-12-12

SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR

Applicant Beckman Coulter, Inc.

K number K013076

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LEH 1998-11-06

VANCOMYCIN EIA ASSAY

Applicant Diagnostic Reagents, Inc.

K number K983280

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LEH 1997-01-13

VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM

Applicant Bayer Corp.

K number K964587

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LEH 1996-09-13

VANCOMYCIN FLEX REAGENT CARTRIDGE

Applicant Dade Intl., Inc.

K number K963267

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LEH 1996-05-09

AXSYM VANCOMYCIN II

Applicant Abbott Laboratories

K number K955851

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LEH 1996-02-16

VANCOMYCIN FPIA REAGENT SET

Applicant Sigma Diagnostics, Inc.

K number K955716

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LEH 1995-09-12

ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN

Applicant Roche Diagnostic Systems, Inc.

K number K953528

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LEH 1995-06-19

CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY

Applicant Ciba Corning Diagnostics Corp.

K number K951059

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LEH 1995-03-10

DUPONT ACA VANCOMYCIN (VANC) METHOD

Applicant The DU Pont Co.

K number K945125

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LEH 1994-06-21

AXSYM VANCOMYCIN

Applicant Abbott Laboratories

K number K940595

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LEH 1992-12-11

OPUS(R) VANCOMYCIN

Applicant Pb Diagnostic Systems, Inc.

K number K924957

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LEH 1990-05-02

COBAS-FP REAGENTS FOR VANCOMYCIN

Applicant Roche Diagnostic Systems, Inc.

K number K901759

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LEH 1990-04-19

MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR

Applicant Innotron of Oregon, Inc.

K number K900708

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LEH 1989-05-22

ACA VANCOMYCIN (VANC) METHOD

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

K number K892900

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LEH 1988-04-19

EMIT VANCOMYCIN ASSAY

Applicant Syva Co.

K number K881040

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LEH 1988-01-21

STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY

Applicant Baxter Healthcare Corp

K number K874438

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LEH 1987-08-17

INNOFLUOR VANCOMYCIN REAGENT SET

Applicant Innotron of Oregon, Inc.

K number K872579

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LEH 1982-08-16

VANCOMYCIN FLUORESCENT IMMUNOASSAY

Applicant American Diagnostic Corp.

K number K822308

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LEH 1982-05-13

TDX TM STREPTOMYCIN

Applicant Abbott Laboratories

K number K821136

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LEH 1981-12-08

TDX VANCOMYCIN

Applicant Abbott Laboratories

K number K813218

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