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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
Bulk (5 x Kits)
12
10
5
600
Published in ANCA (FDA cleared Products)
ANCA Formalin
Standard Kit (12 x Wells)
12
10
1
120
Published in ANCA (FDA cleared Products)
ANCA Ethanol
Bulk (5 x Kits)
12
10
5
600
Published in ANCA (FDA cleared Products)
ANCA Ethanol
Standard Kit (12 x Wells)
12
10
1
120
Published in ANCA (FDA cleared Products)
nDNA, FDA cleared
Bulk (5 x Kits)
10
10
5
500
Published in nDNA (Crithidia Luciliae) (FDA cleared Products)
nDNA, FDA cleared
Standard Kit (10 Wells)
10
10
1
100
Published in nDNA (Crithidia Luciliae) (FDA cleared Products)
ANA HEp-2, FDA cleared
Bulk (5 x Kits)
12
10
5
600
Published in ANA (FDA cleared Products)
ANA HEp-2, FDA cleared
Standard Kit (10 Sildes)
12
10
1
120
Published in ANA (FDA cleared Products)

 

AESKULISA® ELISA Test Kits

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

 

AESQC® Multiparametric Quality Controls (FDA listed)

Pool Mix
5 x 500 μl
(1x500μl Pool 1) + (1x500μl Pool 2) + (1x500μl Pool 3) + (1x500μl Pool 4) + (1x500μl Pool 5)
Published in Multiparametric
Pool 5
2 x 500 μl
hRF IgM isotype, CCP IgG isotype, LCP igG isotype (Linear citrullinated peptides)
Published in Multiparametric
Pool 4
2 x 500 μl
TPO, TG, Glia IgA and IgG, tTg IgA, MPO, PR3, GBM
Published in Multiparametric
Pool 3
2 x 500 μl
aCL IgM, aPL IgM, B2GP1 IgG and IgM, DNA (ELISA & FARR)
Published in Multiparametric
Pool 2
2 x 500 μl
aCL IgG, aPL IgG, B2GP1 IgG and IgM, DNA (ELISA & FARR)
Published in Multiparametric
Pool 1
2 x 500 μl
SS-A 60 kDA, SS-A 52 kDA, SS-B, Sm, Sm/RNP, Ribo, CEN-P-B, Jo-1, Scl-70, AMA
Published in Multiparametric