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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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The PG5701 Detection Reagent is used for amplification of the HLA-B*5701 allele.
PHARMIGENE, Inc.
PG-5701A-024
In Commercial Distribution

  • 04719872780618 ()


  • HLA class I & II antigen nucleic acid tissue typing IVD, primer
The PG5801 Detection Reagent is used for amplification of the HLA-B*5801 allele.
PHARMIGENE, Inc.
PG-5801A-024
In Commercial Distribution

  • 04719872780441 ()


  • HLA class I & II antigen nucleic acid tissue typing IVD, primer
The PG1502 Detection Reagent is used for amplification of the HLA-B*1502 allele.
PHARMIGENE, Inc.
PG-1502A-024
In Commercial Distribution

  • 04719872780205 ()


  • HLA class I & II antigen nucleic acid tissue typing IVD, primer
No Description
Biomet Orthopedics, LLC
110004132
In Commercial Distribution

  • 00880304567061 ()

  • I
110004132

  • Instrument tray, reusable
SCREW I - CONNECTOR I
Zimmer GmbH
01.04558.309
In Commercial Distribution

  • 00889024387294 ()
01.04558.309

  • Orthopaedic implant-instrument extension adaptor, reusable
1. Antibody coated plate 12x8 wells coated with antibody against calprotectin. Plastic sealed bag containing a desiccant. 2. Enzyme conjugate antibody (IgG) 1 vial containing 15 ml Horse-radish peroxidase-labeled rabbit anti-human calprotectin IgG antibodies in a buffer solution with Proclin 300 as a preservative. Ready-to-use. 3. Substrate 1 vial containing 15 ml substrate reagent (TMB). Ready-to-use 4. Stop Solution 1 vial containing 15 ml H2SO4 (0.5M). Ready-to-use 5. Washing solution (20x) 1 vial containing 50 ml concentrated washing solution. To be diluted with distilled water. 6. Diluent solution (10x) 1 vial containing 20 ml concentrated diluent solution to be diluted with distilled water. 7. Extraction solution (2.5x) 2 vials containing 100 ml concentrated extraction solution to be diluted with distilled water. This concentrated solution is irritating to eyes and skin. 8. Calibrators 6 vials containing 1.5 ml Calprotectin solution at six known concentrations (0, 2.5, 12.5, 25, 50, 150 ng/ml). The value of each Calibrator is printed on the vial label. Ready-to-use. 9. Control 1 1 vial containing 1.5 ml of control 1. Ready-to-use. Do not dilute. The range of values is printed on the vial label. 10. Control 2 1 vial containing 1.5 ml of control 2. Ready-to-use. Do not dilute. The range of values is printed on the vial label.
INOVA DIAGNOSTICS, INC.
704860
In Commercial Distribution

  • 08426950913337 ()


  • Multiple gastrointestinal disease marker IVD, kit, enzyme immunoassay (EIA)
INTENDED USE An enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with β2-glycoprotein I (β2GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). For In Vitro Diagnostic Use Only. SUMMARY AND EXPLANATION OF THE ASSAY The antiphospholipid syndrome (APS) is one of the most common causes of acquired hypercoagulability (thrombophilia) It is frequently diagnosed in the context of a systemic autoimmune disorder such as SLE (secondary APS), however, it may also occur in the absence of an obvious underlying disease (primary APS). Oxidative stress and oxLDL formation are common in patients with SLE and APS suggesting an important relationship between lipid peroxidation and clotting activation (hypercoagulability). The presence of circulating IgG anti-oxLDL-β2GPI antibodies seem to be etiologically important. PRINCIPLE OF THE TEST This test is an indirect ELISA detecting IgG anti-oxLDL-β2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL- β2GPI complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added. Following another wash, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of IgG anti-oxLDL-β2GPI antibody. Results are obtained by reading the OD of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-oxLDL-β2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean O.D.’s. Controls and patient results are determined from the calibration curve. Refer to product package insert.
CORGENIX MEDICAL CORPORATION
11854
Not in Commercial Distribution

  • 00855360006236 ()
11854

  • Oxidized low density lipoprotein-B2-glycoprotein I (OxLDL-B2GPI) complex antibody IVD, kit, enzyme immunoassay (EIA)
1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 00009800016 2. 1 Resuspension buffer (Cat. No. 00009800019) 3. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 1 (Cat. No. 00009800017): 4. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 2 (Cat. 00009800018):
INSTRUMENTATION LABORATORY COMPANY
00009800015
In Commercial Distribution

  • 08426951298778 ()
00009800015

  • Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
1. 1 QUANTA Flash B2GP1 IgM Reagent Cartridge 2. 1 QUANTA Flash B2GP1 IgM Calibrator 1 3. 1 QUANTA Flash B2GP1 IgM Calibrator 2
INOVA DIAGNOSTICS, INC.
701250
In Commercial Distribution

  • 08426951289271 ()


  • Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
1 QUANTA Flash B2GP1 IgG Reagent Cartridge 1 QUANTA Flash B2GP1 IgG Calibrator 1 1 QUANTA Flash B2GP1 IgG Calibrator 2
INOVA DIAGNOSTICS, INC.
701245
In Commercial Distribution

  • 08426951289264 ()


  • Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
1. 1 QUANTA Flash B2GP1 IgA Reagent Cartridge 2. 1 QUANTA Flash B2GP1 IgA Calibrator 1 3. 1 QUANTA Flash B2GP1 IgA Calibrator 2
INOVA DIAGNOSTICS, INC.
701240
In Commercial Distribution

  • 08426951289257 ()


  • Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
1. 1 QUANTA Flash ß2GP1-Domain1 Reagent Cartridge 2. 1 Resuspension buffer 3. 1 Transfer pipet 4. 1 QUANTA Flash ß2GP1-Domain1 Calibrator 1 5. 1 QUANTA Flash ß2GP1-Domain1 Calibrator 2
INOVA DIAGNOSTICS, INC.
701188
In Commercial Distribution

  • 08426950601951 ()


  • Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
1. 1 QUANTA Flash ß2GP1 IgA Reagent Cartridge 2. 1 QUANTA Flash ß2GP1 IgA Calibrator 1 3. 1 QUANTA Flash ß2GP1 IgA Calibrator 2
INOVA DIAGNOSTICS, INC.
701243
In Commercial Distribution

  • 08426950596820 ()


  • Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
1. 1 QUANTA Flash β2GP1 IgM Reagent Cartridge 2. 1 QUANTA Flash β2GP1 IgM Calibrator 1 3. 1 QUANTA Flash β2GP1 IgM Calibrator 2
INOVA DIAGNOSTICS, INC.
701253
In Commercial Distribution

  • 08426950594475 ()


  • Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
1. QUANTA Flash β2GP1 IgG Reagent Cartridge 1. QUANTA Flash β2GP1 IgG Calibrator 1 1. QUANTA Flash β2GP1 IgG Calibrator 2
INOVA DIAGNOSTICS, INC.
701248
In Commercial Distribution

  • 08426950594420 ()


  • Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
"720-830 anti-β2 Glycoprotein I IgG/IgM Test Kit"
DIAMEDIX CORPORATION
720-830
In Commercial Distribution

  • 00817273020402 ()


  • Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, control
No Description
BIOGENEX LABORATORIES
AM880-5M
In Commercial Distribution

  • 00810119671875 ()

  • Total Volume: 6 Milliliter
AM880-5M

  • Multiple gastrointestinal disease marker IVD, reagent
No Description
BIOGENEX LABORATORIES
AM880-10M
In Commercial Distribution

  • 00810119676252 ()

  • Total Volume: 10 Milliliter
AM880-10M

  • Multiple gastrointestinal disease marker IVD, reagent
No Description
BIOGENEX LABORATORIES
AY880-YCD
In Commercial Distribution

  • 00810119679321 ()
AY880-YCD

  • Multiple gastrointestinal disease marker IVD, reagent
RFT HIP I & I PACK
MEDLINE INDUSTRIES, INC.
DYNJ50831B
In Commercial Distribution

  • 10889942861231 ()
DYNJ50831B

  • General surgical procedure kit, non-medicated, single-use
RFT HIP I & I PACK-LF
MEDLINE INDUSTRIES, INC.
PHS816399002A
In Commercial Distribution

  • 10889942920372 ()
  • 40889942920373 ()
PHS816399002A

  • General surgical procedure kit, non-medicated, single-use
CHN OR HIP I&I
MEDLINE INDUSTRIES, INC.
DYNJ905983F
In Commercial Distribution

  • 10195327605384 ()
DYNJ905983F

  • General surgical procedure kit, non-medicated, single-use
CHN OR HIP I&I
MEDLINE INDUSTRIES, INC.
DYNJ905983C
In Commercial Distribution

  • 10193489828252 ()
DYNJ905983C

  • General surgical procedure kit, non-medicated, single-use
CHN OR HIP I&I
MEDLINE INDUSTRIES, INC.
DYNJ905983D
In Commercial Distribution

  • 10193489916829 ()
DYNJ905983D

  • General surgical procedure kit, non-medicated, single-use
RFT HIP I & I PACK-LF
MEDLINE INDUSTRIES, INC.
PHS816399002
In Commercial Distribution

  • 10889942042593 ()
PHS816399002

  • General surgical procedure kit, non-medicated, single-use
CHN OR HIP I&I
MEDLINE INDUSTRIES, INC.
DYNJ905983
Not in Commercial Distribution

  • 10193489598490 ()
DYNJ905983

  • General surgical procedure kit, non-medicated, single-use
CHN OR HIP I&I
MEDLINE INDUSTRIES, INC.
DYNJ905983B
In Commercial Distribution

  • 10193489399158 ()
DYNJ905983B

  • General surgical procedure kit, non-medicated, single-use
CHN OR HIP I&I
MEDLINE INDUSTRIES, INC.
DYNJ905983A
In Commercial Distribution

  • 10193489779646 ()
DYNJ905983A

  • General surgical procedure kit, non-medicated, single-use
I
AMERICAN CONTRACT SYSTEMS, INC.
JEIR37C
In Commercial Distribution

  • 00191072025050 ()


  • General surgical procedure kit, non-medicated, single-use
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-3
In Commercial Distribution

  • 00856743007048 ()
150-3

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-2
In Commercial Distribution

  • 00856743007031 ()
150-2

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150-1
In Commercial Distribution

  • 00856743007024 ()
150-1

  • Multiple cardiac marker IVD, control
MORE DIAGNOSTICS' CARDIAC MARKERS CONTROL is intended to be used as an assayed control material for the measurement of CKMB, troponin, myoglobin, and C-Reactive Protein (CRP).
MORE DIAGNOSTICS INC
150
In Commercial Distribution

  • 00856743007017 ()
150

  • Multiple cardiac marker IVD, control
No Description
CRITICAL CARE DIAGNOSTICS, INC.
BC-1065x
In Commercial Distribution

  • 00867556000171 ()


  • Multiple cardiac marker IVD, control
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401db
In Commercial Distribution

  • 00859110005616 ()

  • 2 tests
401db

  • Multiple cardiac marker IVD, control
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401bc
In Commercial Distribution

  • 00859110005609 ()

  • 2 tests
401bc

  • Multiple cardiac marker IVD, control
Validate CM1 is intended for the quantitative determination of Calibration Verification/Linearity on automated instruments.
Lgc Clinical Diagnostics, Inc.
401ab
In Commercial Distribution

  • 00859110005593 ()

  • 2 tests
401ab

  • Multiple cardiac marker IVD, control
Kendall DL ECG Cable and Lead Wire System, 5-Lead, Single Patient Use
Cardinal Health 200, LLC
33111
In Commercial Distribution

  • 20192253062752 ()
  • 10192253062755 ()
  • 50192253062753 ()
33111

  • Electrocardiographic lead switching adaptor
Kendall DL ECG Cable and Lead Wire System, 3-Lead, Single Patient Use
Cardinal Health 200, LLC
33103
In Commercial Distribution

  • 20192253062721 ()
  • 10192253062724 ()
  • 50192253062722 ()
33103

  • Electrocardiographic lead switching adaptor
True content to be populated as part of rebranding
Cardinal Health, Inc.
33534
In Commercial Distribution

  • 20884527022110 ()
  • 10884527022113 ()
33534-

  • Electrocardiographic lead switching adaptor
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