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1. Aptiva Celiac Disease IgA Reagent Cartridge contains reagents to process 250 samples.
a. tTG, DGP, and Control paramagnetic particles, preserved.
b. Assay Buffer – colored pink, containing protein stabilizers and preservatives.
c. PE Tracer IgA – PE labeled anti-human IgA antibody, containing buffer, protein stabilizers and preservative.
d. Rehydration Buffer - containing protein stabilizers and preservatives
INOVA DIAGNOSTICS, INC.
724120
In Commercial Distribution
- 08430793040532 ()
- Multiple Coeliac disease-associated antibody IVD, kit, multiplex
1. Aptiva Celiac IgG Reagent Cartridge contains reagents to process 200 samples.
a. tTG, DGP, and Control paramagnetic particles, preserved.
b. Assay Buffer – colored pink, containing protein stabilizers and preservatives.
c. PE Tracer IgG – PE labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative.
d. Rehydration Buffer - containing protein stabilizers and preservatives
INOVA DIAGNOSTICS, INC.
724100
In Commercial Distribution
- 08430793040471 ()
- Multiple Coeliac disease-associated antibody IVD, kit, multiplex
1. 1 QUANTA Flash h-tTG IgA reagent cartridge
2. 1 Resuspension buffer
3. 1 Transfer pipet
INOVA DIAGNOSTICS, INC.
701100
In Commercial Distribution
- 08426950601890 ()
- Tissue transglutaminase antibody IVD, kit, chemiluminescent immunoassay
1. 10x CCP3 IgG ELISA microwell plates (12-1 x 8 wells), with holder
2. 5x 1.2mL prediluted ELISA Negative Control
3. 5x 1.2mL prediluted CCP3 IgG ELISA Low Positive
4. 5x 1.2mL prediluted CCP3 IgG ELISA High Positive/Calibrator A
5. 5x 1.2mL prediluted CCP3 IgG ELISA Calibrator B
6. 5x 1.2mL prediluted CCP3 IgG ELISA Calibrator C
7. 5x 1.2mL prediluted CCP3 IgG ELISA Calibrator D
8. 5x 1.2mL prediluted CCP3 IgG ELISA Calibrator E
9. 9x 50mL HRP Sample Diluent
10. 10x 25mL HRP Wash Concentrate, 40x concentrate
11. 10x 10mL HRP CCP3 IgG Conjugate, (goat), anti-human IgG
12. 10 x10mL TMB Chromogen
13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
704535.10
In Commercial Distribution
- 08426950593393 ()
- Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)
1. 1x h-tTG/DGP Screen ELISA microwell plate (12-1 x 8 wells), with holder
2.1x 1.2mL prediluted ELISA Negative Control
3. 1x 1.2mL prediluted h-tTG/DGP Screen ELISA Low Positive
4. 1x 1.2mL prediluted h-tTG/DGP Screen ELISA High Positive
5. 1x 50mL HRP Sample Diluent
6. 1x 25mL HRP Wash Concentrate, 40x concentrate
7. 1x 10mL HRP h-tTG/DGP IgG/IgA, (goat), anti-human IgG and IgA
8. 1x 10mL TMB Chromogen
9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
704575
In Commercial Distribution
- 08426950593300 ()
- Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)
1. 25 x Monkey Oesophagus – 10-well slide
2. 1 x 1mL Pemphigus Positive Control (prediluted)
3. 1 x 1mL Endomysial (Celiac) Positive Control (prediluted)
4. 1 x 1mL IFA System Negative Control (prediluted)
5. 1 x 15mL FITC IgG (H&L), monkey adsorbed Conjugate
6. 1 x 15mL Anti-Human IgA (α) AFF FITC
7. 1 x 3mL 1% Evans Blue Counterstain
8. 2 x 25mL PBS II concentrate (x40)
9. 1 x 10mL Mounting Medium
10. 25 x Coverslips
11. 1 x instruction leaflet
INOVA DIAGNOSTICS, INC.
704150
In Commercial Distribution
- 08426950557586 ()
- Skin antibody IVD, kit, fluorescent immunoassay
- Endomysium antibody (EMA) IVD, kit, fluorescent immunoassay
1. QUANTA Flash LKM-1 reagent cartridge contains the following reagents for 50 determinations:
a. LKM-1 coated paramagnetic beads, lyophilized.
b. Assay buffer – colored pink, containing protein stabilizers and preservatives.
c. Tracer IgG – Isoluminol labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative.
2. Resuspension buffer - colored clear, containing buffer, protein stabilizers and preservatives."
INOVA DIAGNOSTICS, INC.
701298
In Commercial Distribution
- 08426950767008 ()
- Liver-kidney microsome 1 antibody (anti-LKM1) IVD, kit, chemiluminescent immunoassay
1. 1 QUANTA Flash CCP3 Reagent Cartridge
2. 1 Resuspension Buffer 6
3. 1 Transfer pipet
INOVA DIAGNOSTICS, INC.
701125
In Commercial Distribution
- 08426950622208 ()
- Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, chemiluminescent immunoassay
1. 10x h-tTG IgG ELISA microwell plates (12-1 x 8 wells), with holder
2. 5x 1.2mL prediluted ELISA Negative Control
3. 5x 1.2mL prediluted h-tTG IgG ELISA Low Positive
4. 5x 1.2mL prediluted h-tTG IgG ELISA High Positive
5. 9x 50mL HRP Sample Diluent
6. 10x 25mL HRP Wash Concentrate, 40x concentrate
7. 10x 10mL HRP IgG Conjugate, (goat), anti-human IgG
8. 10x 10mL TMB Chromogen
9. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708755.10
In Commercial Distribution
- 08426950596158 ()
- Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)
1. 1x h-tTG Screen ELISA microwell plate (12-1 x 8 wells), with holder
2. 1x 1.2mL prediluted ELISA Negative Control
3. 1x 1.2mL prediluted h-tTG Screen ELISA Low Positive
4. 1x 1.2mL prediluted h-tTG Screen ELISA High Positive
5. 1x 50mL HRP Sample Diluent
6. 1x 25mL HRP Wash Concentrate, 40x concentrate
7. 1x 10mL HRP h-tTG IgG/IgA Conjugate, (goat), anti-human IgG and IgA
8. 1x 10mL TMB Chromogen
9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
704570
In Commercial Distribution
- 08426950595922 ()
- Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)