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IMMAGE Immunochemistry Systems PFB Properdin Factor B Reagent
Beckman Coulter, Inc.
447760
In Commercial Distribution
- 15099590224073 ()
447760
- Complement factor B IVD, reagent
Validate LP2 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
507ro
In Commercial Distribution
- 00859110005869 ()
- 2 tests
507ro
- Apolipoprotein A-I (Apo A1) IVD, control
- Apolipoprotein B (Apo B) IVD, control
- Multiple lipid analyte IVD, control
ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2000-0063
In Commercial Distribution
- 00816784020932 ()
- Hepatitis B virus antigen/antibody marker IVD, control
- Multiple blood-borne virus antigen/antibody IVD, control
ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0065
In Commercial Distribution
- 00816784020925 ()
- Hepatitis B virus antigen/antibody marker IVD, control
- Multiple blood-borne virus antigen/antibody IVD, control
CRYOcheck Chromogenic Factor IX is for clinical laboratory use in the quantitative determination of factor IX activity in 3.2% citrated human plasma. It is intended to be used in identifying factor IX deficiency and as an aid in the management of hemophilia B in individuals aged 2 years and older. For in vitro diagnostic use
Precision Biologic Inc
CCCF09
In Commercial Distribution
- 00843876000565 ()
CCCF09
- Coagulation factor IX IVD, kit, chromogenic
Uni-Gold™ C. difficile GDH Controls, 1 Positive and 1 Negative
MARDX DIAGNOSTICS, INC.
1206641
In Commercial Distribution
- 05391516748803 ()
1206641
- Clostridium difficile antigen IVD, control
Uni-Gold™ C. difficile GDH, 20 Tests
MARDX DIAGNOSTICS, INC.
1206640
In Commercial Distribution
- 05391516748797 ()
1206640
- Clostridium difficile antigen IVD, kit, agglutination
The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxicity assay for the detection of C. difficile toxin B in patient specimens. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with patient history.
TECHLAB, INC.
T5003
In Commercial Distribution
- 00857031002264 ()
- Clostridium difficile antigen IVD, kit, cell culture assay
The Clostridium difficile Toxin/Antitoxin Kit is intended for use in conjunction with the tissue culture cytotoxicity assay for the confirmation of Clostridium difficile toxin in patient specimens. The kit includes a toxin control reagent and a specific C. difficile antitoxin for use in a tissue culture assay. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history.
TECHLAB, INC.
T5000
In Commercial Distribution
- 00857031002066 ()
- Clostridium difficile antigen IVD, kit, cell culture assay
The C. DIFFICILE TOX-B TEST is intended for use in conjunction with the tissue culture cytotoxicity assay for the detection of C. difficile toxin B in patient specimens. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with patient history.
TECHLAB, INC.
30399U
Not in Commercial Distribution
- 00857031002073 ()
- Clostridium difficile antigen IVD, kit, cell culture assay
No Description
DIAGNOSTICA STAGO
00724
In Commercial Distribution
- 13607450007241 ()
- 03607450007244 ()
- Coagulation factor IX IVD, kit, clotting
Coxsackie A9/A24 Control Slide
EMD Millipore Corporation
50209
Not in Commercial Distribution
- 04061841171737 ()
50209
- Coxsackie A/B virus antigen IVD, reagent
Coxsackie B Control Slide
EMD Millipore Corporation
50208
Not in Commercial Distribution
- 04061841171218 ()
50208
- Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B3 Monoclonal Antibody
EMD Millipore Corporation
3306
Not in Commercial Distribution
- 04053252404719 ()
3306
- Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus A Control Slides
EMD Millipore Corporation
5076
Not in Commercial Distribution
- 04053252404290 ()
5076
- Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B5 Monoclonal Antibody
EMD Millipore Corporation
3308
Not in Commercial Distribution
- 04053252332371 ()
3308
- Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B1 Monoclonal Antibody
EMD Millipore Corporation
3304
Not in Commercial Distribution
- 04053252326264 ()
3304
- Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus A24 Monoclonal Antibody
EMD Millipore Corporation
3302
Not in Commercial Distribution
- 04053252326011 ()
3302
- Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B Blend Monoclonal Antibodies
EMD Millipore Corporation
3303
Not in Commercial Distribution
- 04053252734557 ()
3303
- Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B Control Slides
EMD Millipore Corporation
5075
Not in Commercial Distribution
- 04053252729225 ()
5075
- Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus A9 Monoclonal Antibody
EMD Millipore Corporation
3301
Not in Commercial Distribution
- 04053252672989 ()
3301
- Coxsackie A/B virus antigen IVD, reagent
Coxsackie Antibody Set
EMD Millipore Corporation
3350
Not in Commercial Distribution
- 04053252585258 ()
3350
- Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B2 Monoclonal Antibody
EMD Millipore Corporation
3305
Not in Commercial Distribution
- 04053252516092 ()
3305
- Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B6 Monoclonal Antibody
EMD Millipore Corporation
3309
Not in Commercial Distribution
- 04053252472985 ()
3309
- Coxsackie A/B virus antigen IVD, reagent
Coxsackievirus B4 Monoclonal Antibody
EMD Millipore Corporation
3307
Not in Commercial Distribution
- 04053252408489 ()
3307
- Coxsackie A/B virus antigen IVD, reagent
HemosIL Chromogenic Factor IX
INSTRUMENTATION LABORATORY COMPANY
0020012900
In Commercial Distribution
- 00195226001129 ()
0020012900
- Coagulation factor IX IVD, kit, chromogenic
HemosIL Factor IX Deficient Plasma (10 X 1 mL)
INSTRUMENTATION LABORATORY COMPANY
00020011900
In Commercial Distribution
- 08426950478553 ()
- 18426950478550 ()
00020011900
- Coagulation factor IX IVD, kit, clotting
Easy Lab Pro RSV - US
AMERICAN BIO MEDICA CORPORATION
10-RSV-ELP
In Commercial Distribution
- 10694644750031 ()
- 10694644700036 ()
10-RSV-ELP
- Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator
RSV Test Kit European 135065
AMERICAN BIO MEDICA CORPORATION
10-RSV-065
In Commercial Distribution
- 10694644700029 ()
- 10694644750024 ()
10-RSV-065
- Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator
RSV Test Kit US Version 135060
AMERICAN BIO MEDICA CORPORATION
10-RSV-060
In Commercial Distribution
- 10694644700012 ()
- 10694644750017 ()
10-RSV-060
- Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator
Farr Style Spring Retractor single prongs L blade
Avalign Technologies, Inc.
63-G5098F3
In Commercial Distribution
- 00190776193430 ()
- A/B transferase IVD, calibrator
Turner Warwick Ret Mal Blde
Avalign Technologies, Inc.
63-GU8261004
In Commercial Distribution
- 00190776193423 ()
- A/B transferase IVD, calibrator
Assistant ee Soft Tissue blade standard
Avalign Technologies, Inc.
63-745009A
In Commercial Distribution
- 00190776193416 ()
- A/B transferase IVD, calibrator
Clis Taylor Retr wide blade
Avalign Technologies, Inc.
63-59401005
In Commercial Distribution
- 00190776193409 ()
- A/B transferase IVD, calibrator
INITIAL INCIS RETR SMSHRT BLADE
Avalign Technologies, Inc.
63-52706S
In Commercial Distribution
- 00190776193393 ()
- A/B transferase IVD, calibrator
Middle Arm for Modified Kbel Retractor
Avalign Technologies, Inc.
63-246173
In Commercial Distribution
- 00190776193362 ()
- A/B transferase IVD, calibrator
Middle Arm for Modified Kbel Retractor
Avalign Technologies, Inc.
63-246175
In Commercial Distribution
- 00190776193386 ()
- A/B transferase IVD, calibrator
Middle Arm for Modified Kbel Retractor
Avalign Technologies, Inc.
63-246174
In Commercial Distribution
- 00190776193379 ()
- A/B transferase IVD, calibrator
Factor IX immunodepleted 10 x 1 ml
R 2 DIAGNOSTICS, INC.
69-201
In Commercial Distribution
- 10859394006160 ()
- 00859394006163 ()
69-201
- Coagulation factor IX IVD, kit, clotting
Taylor Spinal Retractor, 1 1/4" wide x 6" deep blade, 7 1/4" OL
Avalign Technologies, Inc.
63-731079
In Commercial Distribution
- 00190776393106 ()
- A/B transferase IVD, calibrator
No Description
Bion Enterprises, Ltd.
IB-2112
In Commercial Distribution
- B110IB21120 ()
IB-2112
- Influenza B virus immunoglobulin G (IgG) antibody IVD, reagent
Group B Latex Reagent
PRO-LAB, INCORPORATED
PL.1032
In Commercial Distribution
- 10628429001339 ()
PL.1032
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, reagent
No Description
TCOAG IRELAND LIMITED
T1509
In Commercial Distribution
- 15391521420418 ()
- 05391521420411 ()
- Coagulation factor IX IVD, kit, clotting
NeuMoDx GBS Test Strip
Neumodx Molecular, Inc.
200400
Not in Commercial Distribution
- 10814278020045 ()
- 00814278020048 ()
200400
- Beta-haemolytic Group B Streptococcus nucleic acid IVD, reagent
No Description
OXOID LIMITED
R244596
In Commercial Distribution
- 05032384519903 ()
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
Toxi-Titer Plate, 48 Wells
MARDX DIAGNOSTICS, INC.
B1029-70D
In Commercial Distribution
- 05391516747998 ()
B1029-70D
- Clostridium difficile toxin A/B antigen IVD, reagent
Bartels® Cytotoxicity Assay for Clostridium difficile Toxin Product B1029-70, Store Toxi-Titer Plate @ 35-37 °C, Store Reagents @ 2-8 °C, 48 Tests
MARDX DIAGNOSTICS, INC.
B1029-70
In Commercial Distribution
- 05391516747950 ()
B1029-70
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
The C. DIFF CHEK™ - 60 test is an enzyme immunoassay for use as a screening test to detect Clostridium difficile antigen, glutamate dehydrogenase, in fecal specimens
from persons suspected of having C. difficile disease. The test does not distinguish toxigenic from nontoxigenic strains of C. difficile. With the use of additional tests that
detect C. difficile toxins, this test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with
patient history.
TECHLAB, INC.
TL5025
In Commercial Distribution
- 00857031002660 ()
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
The C. DIFFICILE TOX A/B II™ test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history.
TECHLAB, INC.
T5015XB
In Commercial Distribution
- 00857031002646 ()
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)
The TECHLAB® C. DIFF QUIK CHEK COMPLETE® test is a rapid membrane enzyme immunoassay for the simultaneous detection of Clostridium difficile glutamate dehydrogenase antigen and toxins A and B in a single reaction well. The test detects
C. difficile antigen, glutamate dehydrogenase, as a screen for the presence of C. difficile and confirms the presence of toxigenic C. difficile by detecting toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease. As with other C. difficile tests, results should be considered in conjunction with the patient history.
TECHLAB, INC.
T5038
Not in Commercial Distribution
- 00857031002554 ()
- Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)