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Devyser Compact

Detect the most common aneuploidies using a single-tube PCR test that delivers fast and accurate results with minimal lab handling time. The single PCR mix reliably detects abnormalities in chromosomes 13, 18, 21, X and Y. Did you know that Devyser has IP rights for Turner markers?

1 tube per sample

26

Markers covering your needs

45

<45 minutes of hands-on time

IVDR certified

Product information

Proven accuracy, specificity, and sensitivity

Devyser Compact is now certified according to the new CE-IVD Regulation (IVDR) and is a prenatal genetic test that aids in diagnosing the most common chromosomal aneuploidies and it is often used as a confirmatory test after other methods, e.g., non-invasive prenatal testing (NIPT). Compact is designed with the “1 tube” concept in mind to simplify laboratory work and minimize the risk of sample mix-up. Since 2007, our goal has been to serve diagnostic laboratories with simple, rapid, accurate, and relevant QF-PCR tests. Now, we enter the IVDR era, and we strive to continue to be the company you can turn to.

WORKFLOW - Simple, accurate, and rapid

Devyser’s single-tube approach reduces hands-on time to less than 45 minutes and minimizes the risk of sample mix-up or cross-contamination. The test kit is simple and straightforward for lab technicians to use, making it a good choice for any laboratory. < 45 minutes hands-on time <4.5 hours total time to analyzed results All reagents needed to perform QF-PCR analysis are included. Common PCR- and genetic analyzer instruments validated.

Proven performance

The clinical evidence for scientific validity, analytical performance, and clinical performance of Devyser Compact was evaluated. The test exhibits fully consistent results for 204 samples compared to karyotyping as the gold standard. The work was performed with external collaborators and at the Devyser research laboratory. Amongst the sample specimens used: were chorionic villi (CV) biopsies, amniotic fluid (AF), and whole blood (WB). The study is presented in the Devyser Compact IFU chapter 11.

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Instructions for use

Enter access code found in the lower right corner of the label on the kit box.

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Certificates

Download a specific Batch Release Certificate (BRC) below.

Guidelines and handbooks (8)

Accessory Pack QF-PCR version 2024-10 (English)

pdf

Download

Data Analysis Using GeneMapper 2018-12-10 (English)

pdf

Download

Handbook Devyser Compact v3 RUO EN v2-2013 (English)

pdf

Download

Addendum to handbook Devyser SeqStudio QF-PCR products 7-B910 v2023-03-30 (English)

490 kb pdf

Download

Addendum to handbook Devyser VeritiPro QF-PCR products 7-B904 v2023-03-31 (English)

100 kb pdf

Download

Best practice guidelines for use of QF-PCR for the detection of aneuploidy (English)

pdf

Download

Addendum to Handbook 560 SIZER ORANGE Correction storage requirements 7-B917 v2024-09-13 (English)

106 kb pdf

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Addendum to Handbook Dev-5 Dye Set MultiCap Correction storage requirements 7-B916 v2024-09-13 (English)

121 kb pdf

Download

Product information (5)

Flyer_Devyser Compact v3ct (English)

pdf

Download

Booklet_Prenatal QF-PCR (English)

pdf

Download

Devyser_Compact_IVDR_flyer_2023-08-23 (French)

262 kb pdf

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Devyser_Compact_IVDR_flyer_2023-06-28 (Italian)

793 kb pdf

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Devyser_Compact_IVDR_flyer_2023-04-05 (English)

709 kb pdf

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Software settings (8)

QF-PCR Results Interpretation v2018-12-10, c2019-05-02 (English)

pdf

Download

GeneMapper Settings Devyser Compact v3_GM4-5_2018-01-10 (English)

zip

Download

Fragment Analysis Using ABI PRISM 310_2020-06-15 (English)

pdf

Download

Fragment Analysis Using ABI 3730 & 3730xL 2020-06-15 (English)

pdf

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Fragment Analysis Using ABI 3130 & 3130xL 2020-06-15 (English)

pdf

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Fragment Analysis Using ABI 3500 & 3500xL 2020-06-15, c2021-01-19 (English)

pdf

Download

Fragment analysis using SeqStudio v2023-02-13 (English)

pdf

Download

Devyser Seqstudio Settings v.2022-12-29 (English)

4 kb

Download

Safety data sheets (1)

SDS Devyser FA products 7-A429 v2024-01-10 (English)

569 kb pdf

Download

Data tables (0)

Enter access code found in the lower right corner of the label on the kit box.

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Product details

CE-IVDR

Devyser Compact

Aneuploidy determination of chromosomes 13, 18, 21, X and Y

8-R017-25

8-R017-50

8-R017-100

Pack size: 25

Pack size: 50

Pack size: 100

CE-IVD

Devyser Compact v3

Aneuploidy determination of chromosomes 13, 18, 21, X and Y

8-A017.3-25

8-A017.3-50

8-A017.3-100

Pack size: 25

Pack size: 50

Pack size: 100

RUO

Devyser Compact v3 RUO

Aneuploidy determination of chromosomes 13, 18, 21, X and Y

8-A017.3-25-RUO

8-A017.3-50-RUO

8-A017.3-100-RUO

Pack size: 25

Pack size: 50

Pack size: 100

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Disclaimer: Products mentioned here are CE-IVD marked but not FDA-cleared. Availability in each country depends on local regulatory marketing authorization status. Please consult your local sales representative for details.