Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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B. burgdorferi EIA (IgG, IgM) Test System (96 Tests)
MARDX DIAGNOSTICS, INC.
40-8696P
In Commercial Distribution

  • 05391516746298 ()
40-8696P

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
No Description
IMMUNETICS, INC.
DK-E352-096
In Commercial Distribution

  • 00863782000305 ()


  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Epstein-Barr virus (EBV) VCA immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB VCA M
In Commercial Distribution

  • 00850487007173 ()
Q01-480

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Epstein-Barr virus (EBV) VCA immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB VCA M
In Commercial Distribution

  • 00850487007418 ()
Q01-480

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
The MERIFLUOR EBV VCA IgM IFA Test is a sensitive and rapid immunofluorescence method for the qualitative detection of antibodies to the Viral Capsid Antigen (VCA) of Epstein-Barr virus (EBV) in human serum. It is of value in providing supportive information for the diagnosis of active infection with EBV.
MERIDIAN BIOSCIENCE, INC.
EB150
Not in Commercial Distribution

  • 00840733101946 ()
EB150

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
No Description
DIASORIN MOLECULAR LLC
IF0010
Not in Commercial Distribution

  • 10816101020017 ()


  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent
No Description
Ventana Medical Systems, Inc.
05267935001
In Commercial Distribution

  • 04015630971510 ()
05267935001

  • Human immunoglobulin M (IgM) animal conjugate antibody reagent IVD
The Borrelia burgdorferi IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgM class antibody to Borrelia burgdorferi in human serum. This assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme disease.
DRG International Inc
EIA-2811
In Commercial Distribution

  • 00840239028112 ()
EIA-2811

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The Borrelia burgdorferi IgG ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibody to Borrelia burgdorferi in human serum. This assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme disease
DRG International Inc
EIA-2810
In Commercial Distribution

  • 00840239028105 ()
EIA-2810

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The Borrelia burgdorferi IgG/IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG and IgM class antibodies to Borrelia burgdorferi in human serum. This assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme disease
DRG International Inc
EIA-2809
In Commercial Distribution

  • 00840239028099 ()
EIA-2809

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The DRG Epstein Barr Virus – Viral Capsid antigen (EBV-VCA) IgM test system is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human serum.
DRG International Inc
EIA-2794
Not in Commercial Distribution

  • 00840239027948 ()
EIA-2794

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Rapid Mono Test Device. (Whole Blood/Serum/Plasma)
JANT PHARMACAL CORPORATION
ID516
In Commercial Distribution

  • 10763924516299 ()
  • 00763924516292 ()


  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ Borrelia burgdorferi IgG/IgM is an enzyme-linked immunosorbent assay (ELISA) for the qualitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This ELISA should only be used for patients with signs and symptoms that are consistent with Lyme disease. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. Positive supplemental results are supportive evidence of exposure to B. burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
Diagnostic Automation, Inc.
DACD-1423-2
In Commercial Distribution

  • 00894175000022 ()

  • 96 tests
1423-2

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
BioPlex 2200 Lyme Total Assay Protocol File CD SW4.3_v1.0
BIO-RAD LABORATORIES, INC.
4.3_v1.0
In Commercial Distribution

  • 03610520506462 ()

  • 1 Each
12000883

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
U.S. IFU, Canada IFU (United States, Canada) Manual & CDs, BioPlex 2200 Lyme Total IFU SW4.3_v1.0
BIO-RAD LABORATORIES, INC.
4.3_v1.0
In Commercial Distribution

  • 03610520506455 ()

  • 1 Each
12000882

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
BioPlex 2200 Lyme Total 200 Tests
BIO-RAD LABORATORIES, INC.
12000876
In Commercial Distribution

  • 03610520506394 ()

  • 200 Tests
12000876

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
No Description
Diasorin Inc.
318330
In Commercial Distribution

  • 08056771602709 ()


  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
No Description
Diasorin Inc.
310870
In Commercial Distribution

  • 08056771600262 ()
  • 18056771600269 ()


  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
No Description
DIASORIN SPA
310500
In Commercial Distribution

  • 08056771101677 ()


  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
The VIDAS ® Lyme IgG and IgM assay for use on VIDAS family instruments for the presumptive detection of total antibodies (IgG/IgM) to Borrelia burgdorferi
BIOMERIEUX SA
30298-01
Not in Commercial Distribution

  • 03573026156879 ()


  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Gold Standard Diagnostics Is-EBV-EA-D IgM Test Kit
Gold Standard Diagnostics Corporation
720-650
In Commercial Distribution

  • B3507206500 ()
720-650

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
ImmunoSimplicity (Is) EBNA-1 IgM ELISA Test Kit for the qualitative determination of IgM antibodies to Epstein-Bar Virus Nuclear Antigen-1 (EBNA-1 IgM) in human serum by indirect enzyme immunoassay.
Gold Standard Diagnostics Corporation
720-630
In Commercial Distribution

  • B3507206300 ()
720-630

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit
Gold Standard Diagnostics Corporation
720-610
In Commercial Distribution

  • B3507206100 ()
720-610

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Bion Enterprises, Ltd.
EBM-120
In Commercial Distribution

  • B110EBM1200 ()
EBM-120

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
IgG Removal Reagent
SCIMEDX CORPORATION
CB004
In Commercial Distribution

  • 00813545023843 ()
CB004

  • Human immunoglobulin M (IgM) animal conjugate antibody reagent IVD
Detection of Epstein Barr Viral Capsid Antigen
ARLINGTON SCIENTIFIC, INC.
NC-880096-AM
In Commercial Distribution

  • 00816057020652 ()

  • 96 Test
NC-880096-AM

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
The Borrelia burgdorferi IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgM class antibody to Borrelia burgdorferi in human serum. This assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme disease.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2811
In Commercial Distribution

  • 04048474028119 ()
EIA-2811

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The Borrelia burgdorferi IgG ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG class antibody to Borrelia burgdorferi in human serum. This assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme disease
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2810
In Commercial Distribution

  • 04048474028102 ()
EIA-2810

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The Borrelia burgdorferi IgG/IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG and IgM class antibodies to Borrelia burgdorferi in human serum. This assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme disease
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2809
In Commercial Distribution

  • 04048474028096 ()
EIA-2809

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The DRG Epstein Barr Virus – Viral Capsid antigen (EBV-VCA) IgM test system is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgM class antibodies to Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) in human serum.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2794
Not in Commercial Distribution

  • 04048474027945 ()
EIA-2794

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2132-9601-24 O
In Commercial Distribution

  • 04049016114895 ()


  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2150-9601 M
Not in Commercial Distribution

  • 04049016027522 ()


  • Legionella pneumophila immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
EB VCA IgM EIA
Bio-RAD Laboratories, Inc.
25185
In Commercial Distribution

  • 00847865010801 ()

  • 96 Tests
25185

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
EBV IgM Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
6651370C
In Commercial Distribution

  • 00847865002455 ()

  • 1 Each
6651370C

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
Anti-Borrelia (Lyme) Microplate EIA
Bio-RAD Laboratories, Inc.
32507
In Commercial Distribution

  • 00847865001274 ()

  • 96 Tests
32507

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
EBV IgM Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865001236 ()

  • 1 Each
6651370D

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
EBV IgG Reagent Pack
BIO-RAD LABORATORIES, INC.
6651350
In Commercial Distribution

  • 00847865000291 ()

  • 100 Tests
6651350

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
Anti-Borrelia (Lyme) EIA, Conjugate
Bio-RAD Laboratories, Inc.
25274
In Commercial Distribution

  • 00847865011495 ()

  • Total Volume: 12 Milliliter
25274

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Borrelia (Lyme) EIA, Borrelia Blocker
Bio-RAD Laboratories, Inc.
25272
In Commercial Distribution

  • 00847865011488 ()

  • Total Volume: 25 Milliliter
25272

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Borrelia (Lyme) EIA, Positive Control
Bio-RAD Laboratories, Inc.
25271
In Commercial Distribution

  • 00847865011471 ()

  • Total Volume: 0.1 Milliliter
25271

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Borrelia (Lyme) EIA, Negative Control
Bio-RAD Laboratories, Inc.
25270
In Commercial Distribution

  • 00847865011464 ()

  • Total Volume: 0.3 Milliliter
25270

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Borrelia (Lyme) EIA Calibrator
Bio-RAD Laboratories, Inc.
25269
In Commercial Distribution

  • 00847865011457 ()

  • Total Volume: 0.3 Milliliter
25269

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Manual & CDs, EBV IgM IFU, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4V2
In Commercial Distribution

  • 00847865011358 ()

  • 1 Each
6651360F

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
Manual & CDs, EBV IgM IFU, SW4.1_v1
BIO-RAD LABORATORIES, INC.
6651360G
In Commercial Distribution

  • 00847865011341 ()

  • 1 Each
6651360G

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
Anti-Borrelia (Lyme) EIA, Stop Solution
Bio-RAD Laboratories, Inc.
25277
In Commercial Distribution

  • 00847865011280 ()

  • Total Volume: 25 Milliliter
25277

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Borrelia (Lyme) EIA , Substrate Concentrate
Bio-RAD Laboratories, Inc.
25276
In Commercial Distribution

  • 00847865011273 ()

  • Total Volume: 1.5 Milliliter
25276

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Borrelia (Lyme) EIA, Substrate Buffer
Bio-RAD Laboratories, Inc.
25275
In Commercial Distribution

  • 00847865011266 ()

  • Total Volume: 25 Milliliter
25275

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Anti-Borrelia (Lyme) EIA, Wash Buffer Concentrate [20X]
Bio-RAD Laboratories, Inc.
25273
In Commercial Distribution

  • 00847865011259 ()

  • Total Volume: 50 Milliliter
25273

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The COVID-19 total Ab is designed for the qualitative and quantitative measurement of anti-coronavirus IgG and IgM in human serum and plasma (Li-heparinized, EDTA, and citrate) by fluorescence immunoassay (FIA) using the FREND™ System.
NanoEnTek, Inc.
FREND COVID-19 total Ab
In Commercial Distribution

  • 08809317540924 ()
FRCOA 020

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
B. burgdorferi Wash Buffer (10x)
CLARK LABORATORIES, INC.
40-1013
In Commercial Distribution

  • 05391516747547 ()

  • Total Volume: 100 Milliliter
40-1013

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
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