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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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Rowley Biochemical Harris Hematoxylin - SO942852042008

Harris Hematoxylin without Mercury
TRANSENE COMPANY, INC.
1
In Commercial Distribution

  • SO942852042008 ()

  • Total Volume: 1 Gallon
  • Total Volume: 1 Quart
  • Total Volume: 1 Pint
  • Total Volume: 8 Fluid Ounce
  • Total Volume: 4 Fluid Ounce


  • Haematoxylin and eosin (H&E) stain control IVD, kit

Diamedix - 00817273020280

"720-480 anti-Cardiolipin Screen"
DIAMEDIX CORPORATION
720-480
In Commercial Distribution

  • 00817273020280 ()


  • Anti-E [RH0003] antibody screen IVD, control

E. coliPRO™ - 00819398027953

E. coliPRO™ O157 Latex Kit, rapid latex agglutination test for E. coli O157, 50 tests A rapid latex agglutination test kit for the identification of the E. coli O157 serotype. So sensitive that it requires only one single colony. Uses proprietary antibodies that eliminate the possibility of cross-reactions with Escherichia hermanii and other sorbitol-negative Escherichia species. Contains both positive and negative controls. Includes reaction cards and mixing sticks Each kit contains: E. coliPRO™ O157 Latex Reagent 1 dropper vial/kit E. coliPRO™ O157 Positive Control Suspension 1 dropper vial/kit E. coliPRO™ O157 Negative Control Latex Reagent 1 dropper vial/kit Latex Test Cards 20 cards/kit Mixing Sticks 75 sticks/kit
HARDY DIAGNOSTICS
PL070HD
In Commercial Distribution

  • 00819398027953 ()
PL070HD

  • Escherichia coli antibody IVD, reagent

DJO SURGICAL - 00888912087599

Ceramic Liner - Size 32
Encore Medical, L.P.
498-32-052
In Commercial Distribution

  • 00888912087599 ()


  • Ceramic acetabular liner

DJO SURGICAL - 00888912087537

Ceramic Liner - Size 28
Encore Medical, L.P.
498-28-048
In Commercial Distribution

  • 00888912087537 ()


  • Ceramic acetabular liner

DJO SURGICAL - 00888912087636

Ceramic Liner - Size 32
Encore Medical, L.P.
498-32-064
In Commercial Distribution

  • 00888912087636 ()


  • Ceramic acetabular liner

DJO SURGICAL - 00888912087629

Ceramic Liner - Size 32
Encore Medical, L.P.
498-32-060
In Commercial Distribution

  • 00888912087629 ()


  • Ceramic acetabular liner

DJO SURGICAL - 00888912087612

Ceramic Liner - Size 32
Encore Medical, L.P.
498-32-056
In Commercial Distribution

  • 00888912087612 ()


  • Ceramic acetabular liner

Oxeye Daisy Chrysanth. leucanthemum - 00816879022032

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
W007
Not in Commercial Distribution

  • 00816879022032 ()
744470

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

Foxtail, Meadow Alopecurus pratensis - 00816879022025

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.
HYCOR BIOMEDICAL LLC
G016
Not in Commercial Distribution

  • 00816879022025 ()
743420

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
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