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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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AUTO I.D.® Sm/RNP Autoantibody Test System - M7490600111

AUTO I.D.® RNP Control - 1 x 0.5 ml
IMMUNO CONCEPTS INC
6001 (1)
In Commercial Distribution

  • M7490600111 ()
6001 (1)

  • U1-RNP antibody IVD, control

Colorzyme® ANA Test System - M7490407511

ANA IgG Enzyme Antibody Reagent 1 x 23 mls.
IMMUNO CONCEPTS INC
4075 (1)
In Commercial Distribution

  • M7490407511 ()
4075 (1)

  • Multiple antinuclear antibody (ANA) screening IVD, reagent

HEp-2000® Colorzyme® ANA-Ro Test System - M7490406651

Color Reagent Powder - 5 x 1 Pkg.
IMMUNO CONCEPTS INC
4066 (5)
In Commercial Distribution

  • M7490406651 ()
4066 (5)

  • Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

IgG Anti-nDNA Fluorescent Test System - M74903200G1

IgG anti-nDNA FA Test System - 280 Tests
IMMUNO CONCEPTS INC
3200G
In Commercial Distribution

  • M74903200G1 ()
3200G

  • Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay

Fluorescent nDNA Test System - M7490307511

nDNA Fluorescent Antibody Reagent 1 x 23 mls.
IMMUNO CONCEPTS INC
3075 (1)
In Commercial Distribution

  • M7490307511 ()
3075 (1)

  • Native DNA antibody (anti-nDNA) IVD, reagent

IgG Anti-nDNA Fluorescent Test System - M74903040G1

IgG anti-nDNA FA Test System - 70 Tests
IMMUNO CONCEPTS INC
3040G
In Commercial Distribution

  • M74903040G1 ()
3040G

  • Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay

Fluorescent nDNA Test System - M7490303111

nDNA Negative Control - 1 x 5 ml
IMMUNO CONCEPTS INC
3031 (1)
In Commercial Distribution

  • M7490303111 ()
3031 (1)

  • Native DNA antibody (anti-nDNA) IVD, control

Fluorescent nDNA Test System - M7490302611

nDNA FA Titratable Control - 2 x 0.5 ml
IMMUNO CONCEPTS INC
3026 (1)
In Commercial Distribution

  • M7490302611 ()
3026 (1)

  • Native DNA antibody (anti-nDNA) IVD, control

Fluorescent nDNA Test System - M7490302111

nDNA Positive Control - 1 x 5 ml
IMMUNO CONCEPTS INC
3021 (1)
In Commercial Distribution

  • M7490302111 ()
3021 (1)

  • Native DNA antibody (anti-nDNA) IVD, control

IgG Anti-nDNA Fluorescent Test System - M74903005G1

IgG anti-nDNA Fluorescent Bulk Pack - 700 Tests
IMMUNO CONCEPTS INC
3005G
In Commercial Distribution

  • M74903005G1 ()
3005G

  • Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay
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