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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The Anti Tissue Transglutaminase-A (Anti-tTg-A) ELISA is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum. Each device contains the following: microplate strips with breakaway microwells coated with recombinant human tTG and Gliadin-specific peptide antigen, six levels of calibrators (0, 3, 10, 30, 100, 300 U/mL); positive, negative and cut-off controls (human serum, diluted); wash buffer concentrate; sample buffer; goat anti-human immunoglobulin (IgG) horseradish peroxidase conjugate; 3,3’,5,5’ tetramethylbenzidine (TMB)/H2O2 substrate; and 1M hydrochloric acid stop solution.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
35-TGAHU-E01
In Commercial Distribution

  • B24235TGAHUE010 ()
35-TGAHU-E01

  • Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)
  • Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)
The Anti-Cardiolipin-A ELISA is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human Beta-2-glycoprotein I (Beta-2-GPI) for the semiquantitative and qualitative detection of IgA antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and Beta-2-GPI which are only expressed when Beta-2-GPI interacts with cardiolipin. The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjunction with other serological tests and clinical findings.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
35-CAAHU-E01
Not in Commercial Distribution

  • B24235CAAHUE010 ()
35-CAAHU-E01

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
The Microalbumin assay procedure is a competitive ELISA in which enzyme labeled albumin competes with albumin in samples for limited antibody binding sites on the microplate. After incubation for a fixed time, separation of bound from free is achieved by simple decantation and plate washing. The enzyme activity on the plate is measured using an enzyme substrate and a chromogen. The absorbency of the color developed is read in an ELISA colorimetric reader. The measured absorbance is inversely proportional to the concentration of bound albumin in the microplate. The concentration of albumin in the urine is determined from a calibration curve.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
24-MABHU-E01
Not in Commercial Distribution

  • B24224MABHUE010 ()
24-MABHU-E01

  • Albumin IVD, kit, enzyme immunoassay (EIA)
The Adrenocorticotropic Hormone ELISA is intended for use in the quantitative determination of ACTH (Adrenocorticotropic Hormone) in human EDTA plasma.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
21-ACTHU-E01
In Commercial Distribution

  • B24221ACTHUE010 ()
21-ACTHU-E01

  • Adrenocorticotropic hormone (ACTH) IVD, kit, enzyme immunoassay (EIA)
The Androstenedione ELISA is for the direct quantitative determination of androstenedione in human serum by an enzyme immunoassay. For In Vitro Diagnostic Use.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
11-ANRHU-E01
In Commercial Distribution

  • B24211ANRHUE010 ()
11-ANRHU-E01

  • Androstenedione IVD, kit, enzyme immunoassay (EIA)
Goat antiserum to Human C-3b Inactivator (factor I)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761210 ()
121002

  • Complement reagent IVD
Goat Antiserum to Human C-3 (b1c only)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761190 ()
119002

  • Complement components C3/C3c IVD, antibody
Goat antiserum to Human Kappa
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761170 ()
117002

  • Kappa/lambda light chain immunoglobulin IVD, antibody
Goat antiserum to Human C-4 (b1e)
KENT LABORATORIES INC
1
In Commercial Distribution

  • B1761090 ()
109002

  • Complement components C4/C4c IVD, antibody
goat antiserum to Human C-3 Proactivator
KENT LABORATORIES INC
1
Not in Commercial Distribution

  • B1761060 ()
106002

  • Complement factor B IVD, kit precipitation/immunodiffusion
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