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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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IFA B. burgdorferi IgG/IgM Test System - 00845533001656

The ZEUS IFA Borrelia burgdorferi IgG/IgM Test System is designed for the qualitative and semi-quantitative presumptive detection of total (IgG and IgM) antibodies to Borrelia burgdorferi in human serum. This Test System 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.
ZEUS SCIENTIFIC, INC.
FA9351GM
In Commercial Distribution

  • 00845533001656 ()
FA9351GM

  • Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

Elecsys Anti-HBe - 04015630940134

Anti-HBe Elecsys E2G 300
Roche Diagnostics GmbH
07026838190
In Commercial Distribution

  • 04015630940134 ()
07026838190

  • Hepatitis B virus e-antigen/antibody IVD, kit, chemiluminescent immunoassay

Atellica™ IM HBsII Confirmatory - 00630414599267

HBsAg Confirmatory (HBsII Conf) - Atellica IM - RGT - 98T
Siemens Healthcare Diagnostics Inc.
10995603
In Commercial Distribution

  • 00630414599267 ()
10995603

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

ADVIA Centaur® HBsAg Conf (Confirmatory) - 00630414472874

HBsAg Conf (Confirmatory) Assay Kit
Siemens Healthcare Diagnostics Inc.
10309058
In Commercial Distribution

  • 00630414472874 ()
3393818

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

IMMULITE® Systems HBsAg Confirmatory Kit - 00630414971544

HBsAg Confirmatory Kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374036
Not in Commercial Distribution

  • 00630414971544 ()
LKCH(D)

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems HBsAg Confirmatory Kit - 00630414947433

HBsAg Confirmatory Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10706825
In Commercial Distribution

  • 00630414947433 ()
L2KCH1(D)

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

Elecsys HBsAg Confirmatory Test - 04015630911110

No Description
Roche Diagnostics GmbH
11820648122
Not in Commercial Distribution

  • 04015630911110 ()
11820648122

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

Elecsys HBsAg Confirmatory Test - 07613336175293

HBsAg Confirmatory Test Elecsys cobas e V2
Roche Diagnostics GmbH
09127127190
In Commercial Distribution

  • 07613336175293 ()
09127127190

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay

Unimed - 06945664822039

Reusable SpO2 Sensor/上海喜鹊/Finger clip/Adult/3.0M/025
Unimed Medical Supplies, Inc.
U410-173D
In Commercial Distribution

  • 06945664822039 ()


  • Pulse oximeter probe, reusable

Unimed - 06945664803991

Reusable SpO2 Sensor/龙美尔/Finger Clip/Adult/3.0M/111
Unimed Medical Supplies, Inc.
U410-64
In Commercial Distribution

  • 06945664803991 ()


  • Pulse oximeter probe, reusable
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