Immunological Test Systems

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Immunology and Microbiology Devices
  7. Immunological Test Systems

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Section
866.5040

Albumin immunological test system.

Section
866.5060

Prealbumin immunological test system.

Section
866.5065

Human allotypic marker immunological test system.

Section
866.5080

<em>Alpha</em>-1-antichymotrypsin immunological test system.

Section
866.5090

Antimitochondrial antibody immunological test system.

Section
866.5100

Antinuclear antibody immunological test system.

Section
866.5110

Antiparietal antibody immunological test system.

Section
866.5120

Antismooth muscle antibody immunological test system.

Section
866.5130

<em>Alpha</em>-1-antitrypsin immunological test system.

Section
866.5150

Bence-Jones proteins immunological test system.

Section
866.5160

<em>Beta</em>-globulin immunological test system.

Section
866.5170

Breast milk immunological test system.

Section
866.5180

Fecal calprotectin immunological test system.

Section
866.5200

Carbonic anhydrase B and C immunological test system.

Section
866.5210

Ceruloplasmin immunological test system.

Section
866.5220

Cohn fraction II immunological test system.

Section
866.5230

Colostrum immunological test system.

Section
866.5240

Complement components immunological test system.

Section
866.5250

Complement C<sub>1</sub> inhibitor (inactivator) immunological test system.

Section
866.5260

Complement C<sub>3b</sub> inactivator immunological test system.

Section
866.5270

C-reactive protein immunological test system.

Section
866.5320

Properdin factor B immunological test system.

Section
866.5330

Factor XIII, A, S, immunological test system.

Section
866.5340

Ferritin immunological test system.

Section
866.5350

Fibrinopeptide A immunological test system.

Section
866.5360

Cohn fraction IV immunological test system.

Section
866.5370

Cohn fraction V immunological test system.

Section
866.5380

Free secretory component immunological test system.

Section
866.5400

<em>Alpha</em>-globulin immunological test system.

Section
866.5420

<em>Alpha</em>-1-glycoproteins immunological test system.

Section
866.5425

<em>Alpha</em>-2-glycoproteins immunological test system.

Section
866.5430

<em>Beta</em>-2-glycoprotein I immunological test system.

Section
866.5440

<em>Beta</em>-2-glycoprotein III immunological test system.

Section
866.5460

Haptoglobin immunological test system.

Section
866.5470

Hemoglobin immunological test system.

Section
866.5490

Hemopexin immunological test system.

Section
866.5500

Hypersensitivity pneumonitis immunological test system.

Section
866.5510

Immunoglobulins A, G, M, D, and E immunological test system.

Section
866.5520

Immunoglobulin G (Fab fragment specific) immunological test system.

Section
866.5530

Immunoglobulin G (Fc fragment specific) immunological test system.

Section
866.5540

Immunoglobulin G (Fd fragment specific) immunological test system.

Section
866.5550

Immunoglobulin (light chain specific) immunological test system.

Section
866.5560

Lactic dehydrogenase immunological test system.

Section
866.5570

Lactoferrin immunological test system.

Section
866.5580

<em>Alpha</em>-1-lipoprotein immunological test system.

Section
866.5590

Lipoprotein X immunological test system.

Section
866.5600

Low-density lipoprotein immunological test system.

Section
866.5620

<em>Alpha</em>-2-macroglobulin immunological test system.

Section
866.5630

<em>Beta</em>-2-microglobulin immunological test system.

Section
866.5640

Infectious mononucleosis immunological test system.

Section
866.5660

Multiple autoantibodies immunological test system.

Section
866.5665

Aquaporin-4 autoantibody immunological test system.

Section
866.5670

Zinc transporter 8 autoantibody immunological test system.

Section
866.5680

Myoglobin immunological test system.

Section
866.5700

Whole human plasma or serum immunological test system.

Section
866.5715

Plasminogen immunological test system.

Section
866.5735

Prothrombin immunological test system.

Section
866.5750

Radioallergosorbent (RAST) immunological test system.

Section
866.5760

Tryptase test system.

Section
866.5765

Retinol-binding protein immunological test system.

Section
866.5775

Rheumatoid factor immunological test system.

Section
866.5785

Anti-<em>Saccharomyces cerevisiae</em> (<em>S. cerevisiae</em>) antibody (ASCA) test systems.

Section
866.5800

Seminal fluid (sperm) immunological test system.

Section
866.5820

Systemic lupus erythematosus immunological test system.

Section
866.5830

Brain trauma assessment test.

Section
866.5860

Total spinal fluid immunological test system.

Section
866.5870

Thyroid autoantibody immunological test system.

Section
866.5880

Transferrin immunological test system.

Section
866.5890

Inter-<em>alpha</em> trypsin inhibitor immunological test system.

Section
866.5900

Cystic fibrosis transmembrane conductance regulator (CFTR) gene mutation detection system.

Section
866.5910

Quality control material for cystic fibrosis nucleic acid assays.

Section
866.5930

Newborn screening test for severe combined immunodeficiency disorder (SCID).

Section
866.5940

Autosomal recessive carrier screening gene mutation detection system.

Section
866.5950

Genetic health risk assessment system.