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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Prolex E. coli O111 Latex Reagent
PRO-LAB, INCORPORATED
PL.1074
In Commercial Distribution

  • 10628429001162 ()
PL.1074

  • Escherichia coli antigen IVD, kit, agglutination
Prolex E. coli O103 Latex Reagent
PRO-LAB, INCORPORATED
PL.1073
In Commercial Distribution

  • 10628429001155 ()
PL.1073

  • Escherichia coli antigen IVD, kit, agglutination
Prolex E. coli O45 Latex Reagent
PRO-LAB, INCORPORATED
PL.1072
In Commercial Distribution

  • 10628429001148 ()
PL.1072

  • Escherichia coli antigen IVD, kit, agglutination
Prolex E. coli O26 Latex Reagent
PRO-LAB, INCORPORATED
PL.1071
In Commercial Distribution

  • 10628429001131 ()
PL.1071

  • Escherichia coli antigen IVD, kit, agglutination
The ProlexTM E. coli Non-O157 Kit provides an easy to use, reliable and affordable way to identify the six most common STEC producing serotypes in North America. The kit uses our blue carboxylated latex particles labelled with antibodies to E. coli O26, E. coli O45, E. coli O103, E. coli O111, E. coli O121 and E. coli O145 to perform a simple agglutination test. This kit is a great addition to our line of products for the detection of STEC especially when used in conjunction with our ProlisaTM EHEC EIA Kit (PL.2001) and the ProlexTM E.coli O157 Latex Agglutination Kit (PL.070B and PL.071B). Each non-O157 kit comes with a negative control and sufficient agglutination cards and mixing sticks.
PRO-LAB, INCORPORATED
PL.1070
In Commercial Distribution

  • 10628429001124 ()
PL.1070

  • Escherichia coli antigen IVD, kit, agglutination
Negative Control Latex Reagent
PRO-LAB, INCORPORATED
PL.076B
In Commercial Distribution

  • 10628429001100 ()
PL.076B

  • Escherichia coli antigen IVD, kit, agglutination
ProlexTM E. coli O157 identifies Escherichia coli strains associated with Haemorrhagic Colitis and Haemolytic Uraemic Syndrome. Results can be obtained in two minutes from a single colony taken directly from selective agar. This unique reagent has been developed to remove common cross reactions with other similar "O" and "H" antigens, in particular E. hermanii. Available in 50 and 100 test formats, each kit has a maximum shelf life of two years from date of manufacture, and includes mixing sticks, agglutination cards, positive and negative controls.
PRO-LAB, INCORPORATED
PL.071B
In Commercial Distribution

  • 10628429001056 ()
PL.071B

  • Escherichia coli antigen IVD, kit, agglutination
ProlexTM E. coli O157 identifies Escherichia coli strains associated with Haemorrhagic Colitis and Haemolytic Uraemic Syndrome. Results can be obtained in two minutes from a single colony taken directly from selective agar. This unique reagent has been developed to remove common cross reactions with other similar "O" and "H" antigens, in particular E. hermanii. Available in 50 and 100 test formats, each kit has a maximum shelf life of two years from date of manufacture, and includes mixing sticks, agglutination cards, positive and negative controls.
PRO-LAB, INCORPORATED
PL.070B
In Commercial Distribution

  • 10628429001049 ()
PL.070B

  • Escherichia coli antigen IVD, kit, agglutination
No Description
HORIBA ABX SAS
1300023905
In Commercial Distribution

  • 03610230007570 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, calibrator
M12028 - Escherichia coli Antiserum O142
MAST GROUP LIMITED
M12028
In Commercial Distribution

  • 15060392377076 ()
M12028

  • Escherichia coli antigen IVD, kit, agglutination
M12023 - Escherichia coli Antiserum O126 - 2ml
MAST GROUP LIMITED
M12023
In Commercial Distribution

  • 15060392377021 ()
M12023

  • Escherichia coli antigen IVD, kit, agglutination
M12022 - Escherichia coli Antiserum O125 - 1 pack of 2ml
MAST GROUP LIMITED
M12022
In Commercial Distribution

  • 15060392377014 ()
M12022

  • Escherichia coli antigen IVD, kit, agglutination
M12021 - Escherichia coli Antiserum O55 - 1 pack of 2ml
MAST GROUP LIMITED
M12021
In Commercial Distribution

  • 15060392377007 ()
M12021

  • Escherichia coli antigen IVD, kit, agglutination
M14270 - Escherichia coli Polyvalent O Antiserum - POLY 3 Factors O86, O114, O125, O127, O128 - 2ml
MAST GROUP LIMITED
M14270
In Commercial Distribution

  • 15060392376314 ()
M14270

  • Escherichia coli antigen IVD, kit, agglutination
M14263 - Escherichia coli Polyvalent O Antiserum - POLY 2 Factors O26, O55, O111, 0119, O126 - 2ml
MAST GROUP LIMITED
M14263
In Commercial Distribution

  • 15060392376307 ()
M14263

  • Escherichia coli antigen IVD, kit, agglutination
Escherichia coli Monovalent O Antiserum - Factor O157 - 2ml
MAST GROUP LIMITED
M12030
In Commercial Distribution

  • 15060392376291 ()
M12030

  • Escherichia coli antigen IVD, kit, agglutination
M12018 - Escherichia coli Monovalent O Antiserum - Factor O127a - 2ml
MAST GROUP LIMITED
M12018
In Commercial Distribution

  • 15060392376284 ()
M12018

  • Escherichia coli antigen IVD, kit, agglutination
No Description
REMEL EUROPE LIMITED
R2474096
In Commercial Distribution

  • 05056080501673 ()


  • Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)
Hematoxylin, 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8830-M250
In Commercial Distribution

  • 00615233001672 ()
8830-M250

  • Haematoxylin and eosin (H&E) stain control IVD, kit
H&E Stain Kit #1
SAKURA FINETEK U.S.A., INC.
6190
In Commercial Distribution

  • 00615233000040 ()
6190

  • Haematoxylin and eosin (H&E) stain control IVD, kit
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 04560189211087 ()


  • Total immunoglobulin E (IgE total) IVD, reagent
The SHIGA TOXIN CHEK test is an enzyme immunoassay for the simultaneous qualitative detection of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test. It is intended for use with human fecal samples from patients with gastrointestinal symptoms to aid in the diagnosis of disease caused by Shiga Toxin producing Escherichia coli (STEC). It may be used directly with human fecal specimens, or broth or plate cultures derived from fecal specimens. The test results should be considered in conjunction with the patient history.
TECHLAB, INC.
T30696
In Commercial Distribution

  • 00857031002417 ()


  • Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)
The SHIGA TOXIN QUIK CHEK™ test is a rapid membrane enzyme immunoassay for the simultaneous qualitative detection and differentiation of Shiga toxin 1 (Stx1) and Shiga toxin 2 (Stx2) in a single test device. It is intended for use with human fecal samples from patients with gastrointestinal symptoms to aid in the diagnosis of disease caused by Shiga toxin producing Escherichia coli (STEC). It may be used with fecal specimens, or broth or plate cultures derived from fecal specimens. The test results should be considered in conjunction with the patient history.
TECHLAB, INC.
T30625
In Commercial Distribution

  • 00857031002196 ()


  • Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)
The ImmunoCard STAT E. coli O157 Plus is a rapid test for the detection of antigens from Shiga toxin-production E. coli O157 as an aid in the diagnosis of E. coli O157:H7 infection. The test can be used to directly test stool specimens, stool in modified Cary-Blair medium or confirmatory stool cultures grown in MacConkey broth of sorbitol MacConkey (SMAC) plates. In the US, ImmunoCard STAT E. coli O157 Plus is not intended for point-of-care use. This device is intended for moderately complex laboratories. In Canada, this device is not intended for point-of-care use.
MERIDIAN BIOSCIENCE, INC.
750530
In Commercial Distribution

  • 00840733101816 ()
750530

  • Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)
The Premier EHEC test is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II (Verotoxins) in stool specimens, broth cultures, from individual colonies or colony sweeps of agar plates. The Premier EHEC test is intended for use as an aid in the diagnosis of enterohemorrhagic E. coli (EHEC) infections.
MERIDIAN BIOSCIENCE, INC.
608096
In Commercial Distribution

  • 00840733101724 ()
608096

  • Escherichia coli antigen IVD, kit, enzyme immunoassay (EIA)
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
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
"720-480 anti-Cardiolipin Screen"
DIAMEDIX CORPORATION
720-480
In Commercial Distribution

  • 00817273020280 ()


  • Anti-E [RH0003] antibody screen IVD, control
Green Pepper-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385757
In Commercial Distribution

  • 00630414996332 ()
F263L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Australian Pine -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386104
In Commercial Distribution

  • 00630414995847 ()
T73L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
False Ragweed -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386157
In Commercial Distribution

  • 00630414995793 ()
W4L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Native Art v 1-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10370468
In Commercial Distribution

  • 00630414988160 ()
A753L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Cat Serum Albumin, Fel d 2)-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10370455
In Commercial Distribution

  • 00630414988146 ()
E220L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Native Ole e 1-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10370467
In Commercial Distribution

  • 00630414982915 ()
A482L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Dog Fennel-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386156
In Commercial Distribution

  • 00630414979205 ()
W46L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Saltbush-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386153
In Commercial Distribution

  • 00630414979182 ()
W37L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Firebush -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386138
In Commercial Distribution

  • 00630414979144 ()
W17L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Rough Marsh Elder -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386137
In Commercial Distribution

  • 00630414979137 ()
W16L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Scale -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386136
In Commercial Distribution

  • 00630414979120 ()
W15L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Goldenrod -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386133
In Commercial Distribution

  • 00630414979106 ()
W12L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Loblolly Pine-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386094
In Commercial Distribution

  • 00630414979038 ()
T43L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
White Hickory-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386092
In Commercial Distribution

  • 00630414979021 ()
T41L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
White Bald Cypress-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386085
In Commercial Distribution

  • 00630414978987 ()
T37L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Locust Tree-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386081
In Commercial Distribution

  • 00630414978963 ()
T280L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Penicillium brevi-compactum-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386030
In Commercial Distribution

  • 00630414978833 ()
M305L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Canary Grass-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385926
In Commercial Distribution

  • 00630414978710 ()
G71L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Perch-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385843
In Commercial Distribution

  • 00630414978666 ()
F65L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Sweet Potato-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385836
In Commercial Distribution

  • 00630414978628 ()
F54L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Chub Mackerel-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385835
In Commercial Distribution

  • 00630414978611 ()
F50L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Haddock-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385826
In Commercial Distribution

  • 00630414978604 ()
F42L2

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