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nDNA (Crithidia luciliae) now FDA cleared with HELIOS System

AESKU Receives FDA 510(k) Clearance for nDNA (Crithidia luciliae) with the HELIOS AUTOMATED IFA SYSTEM.

(Wendelsheim, Germany / Oakland, California,) AESKU.GROUP received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AESKUSLIDES nDNA (Crithidia luciliae) with the new HELIOS AUTOMATED IFA SYSTEM. The kit is the second FDA cleared immunofluorescence assay on the HELIOS, after ANA HEp-2 (cleared in 2016), and will be followed by ANCA and tissue section slides. Read more...

 

AESKUSLIDES® IFA Test Kits

ANCA Formalin  NEW
Bulk (5 x Kits)
12
10
5
600
ANCA Formalin  NEW
Demo Kit (2 x Slides)
12
2
1
24
ANCA Formalin  NEW
Standard Kit (12 x Wells)
12
10
1
120
ANCA Ethanol  NEW
Bulk (5 x Kits)
12
10
5
600
ANCA Ethanol  NEW
Demo Kit (2 x Slides)
12
2
1
24
ANCA Ethanol  NEW
Standard Kit (12 x Wells)
12
10
1
120
nDNA, FDA cleared  NEW
Bulk (5 x Kits)
10
10
5
500
nDNA, FDA cleared  NEW
Demo Kit (2 Slides)
10
2
1
20
nDNA, FDA cleared  NEW
Standard Kit (10 Wells)
10
10
1
100
ANA HEp-2, FDA cleared
Bulk (5 x Kits)
12
10
5
600
ANA HEp-2, FDA cleared
Demo Kit (2 Sildes)
12
2
1
24
ANA HEp-2, FDA cleared
Standard Kit (10 Sildes)
12
10
1
120

 

AESKULISA® ELISA Test Kits

DGP Check (IgA+IgG)
(FDA cleared)
Single-Check
IgA, IgG
Quant.
Qual.
20
0-300 U/ml
-
DGP-G (FDA cleared)
Single-G
IgG
Quant.
Qual.
15
0-300 U/ml
-
DGP-A (FDA cleared)
Single-A
IgA
Quant.
Qual.
15
0-300 U/ml
-
tTg-A (FDA cleared)
Single-A
IgA
Quant.
Qual.
15
0-300 U/ml
-
GLIA-G (FDA cleared)
Single-G
IgG
Quant.
Qual.
15
0-300 U/ml
-
GLIA-A (FDA cleared)
Single-A
IgA
Quant.
Qual.
15
0-300 U/ml
-
ASCA-G (FDA cleared)
Single-G
IgG
Quant.
Qual.
15
0-300 U/ml
-
ASCA-A (FDA cleared)
Single-A
IgA
Quant.
Qual.
15
0-300 U/ml
-
tTg-G (FDA cleared)
Single-G
IgG
Quant.
Qual.
15
0-300 U/ml
-
PR3 sensitive (FDA cleared)
Single-G
IgG
Quant.
Qual.
15
0-300 U/ml
-
MPO (FDA cleared)
Single-G
IgG
Quant.
Qual.
15
0-300 U/ml
-
Cardiolipin-GM (FDA cleared)
Single-GM
IgG, IgM
Quant.
Qual.
15
0-300 U/ml
Harris
Sapporo
Cardiolipin-A (FDA cleared)
Single-A
IgA
Quant.
Qual.
15
0-300 U/ml
Harris
Cardiolipin-Check
(FDA cleared)
Single-Check
IgA, IgG, IgM
Quant.
Qual.
20
0-300 U/ml
-
β2 Glyco-Check
(FDA cleared)
Single-Check
IgA, IgG, IgM
Quant.
Qual.
20
0-300 U/ml
-
β2-Glyco-GM (FDA cleared)
Single-GM
IgG, IgM
Quant.
Qual.
15
0-300 U/ml
Sapporo
β2 Glyco-A (FDA cleared)
Single-A
IgA
Quant.
Qual.
15
0-300 U/ml
-
Jo-1 (FDA cleared)
Single-G
IgG
Quant.
Qual.
15
0-300
U/ml
CDC
Cenp-B (FDA cleared)
Single-G
IgG
Quant.
Qual.
15
0-300
U/ml
CDC
Scl-70 (FDA cleared)
Single-G
IgG
Quant.
Qual.
15
0-300
U/ml
CDC
SS-B (FDA cleared)
Single-G
IgG
Quant.
Qual.
15
0-300
U/ml
CDC
SS-A (FDA cleared)
Single-G
IgG
Quant.
Qual.
15
0-300
U/ml
CDC
Sm (FDA cleared)
Single-G
IgG
Quant.
Qual.
15
0-300
U/ml
CDC
snRNP-C (FDA cleared)
Single-G
IgG
Quant.
Qual.
15
0-300
U/ml
CDC
U1-70 (FDA cleared)
Single-G
IgG
Quant.
Qual.
15
0-300
U/ml
CDC
ENA-6Pro (FDA cleared)
Profile-G
IgG
Semi
Quant.
15
0-100
U/ml
CDC
ENA-6S (FDA cleared)
Screening-G
IgG
Qual.
Calib.
-
CDC
ANA-8Pro (FDA cleared)
Profile-G
IgG
Qual.
Calib.
-
CDC
dsDNA-G (FDA cleared)
Single-G
IgG
Quant.
Qual.
15
0-300 U/ml
WHO
Wo/80
ANA-HEp2 (FDA cleared)
Single-G
IgG
Quant.
Qual.
Calib.
0-300 U/ml
CDC