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United States

Quantigen

10300 Kincaid Dr, Suite 200, 43067, Fishers, IN, United States

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A2LA 4842.01ISO 15189Register refreshed 2026-11-06

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Scope lines
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A2LA certificate
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A2LA accredited scope

What this lab is accredited for

We found no published test standard numbers in this lab’s scope. The full scope as published is below.

Only this lab. Searches the method, matrix and range of each of the 2 scope lines.

A2LA certificate 4842.01 · 2 lines

LineMethodMatrixRange
1-human samples, including Blood; Buffy Coat Cells; Buccal Swab and Saliva Extracted DNA
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Extracted from the scope document; tables may not line up. View scope for the original.

(A2LA Cert. No. 4842.01) 03/02/2026 Page 1 of 1 SCOPE OF ACCREDITATION TO ISO 15189:2022 QUANTIGEN 10300 Kincaid Dr Fishers, IN 43067 Maja Dickson Phone: 317-578-8980 ext. 203 CLINICAL Valid To: April 30, 2028 Certificate Number: 4842.01 In recognition of the successful completion of the A2LA evalua tion process, accreditation is gran ted to this laboratory to perform the following tests on human samples, including Blood, Buffy Coat Cells, Buccal Swab and Saliva Extracted DNA. S pecialty Sub S pecialty Test/Anal yte Method Matrices Pathology Molecular Pathology Arrays and/or Microarrays PCR Buccal Swab and Saliva Extracted DNA Copy Number Variants, qPCR PCR Buccal Swab and Saliva Extracted DNA Factor V Leiden, Molecular Methods PCR Buccal Swab and Saliva Extracted DNA Methylenetetrhydrofolate Reductase, Molecular Method PCR Buccal Swab and Saliva Extracted DNA Nucleic Acid Extraction PCR KingFisher Flex Blood, Buffy Coat Cells, Buccal Swab and Saliva Extracted DNA Pharmacogenetic Assays PCR Buccal Swab and Saliva Extracted DNA Prothrombin, Molecular Methods PCR Buccal Swab and Saliva Extracted DNA Genotypes for Classical HLA Genes NGS Blood, Buffy Coat Cells, Buccal Swab and Saliva Extracted DNA Genotypes for Non-classical HLA Genes NGS Blood, Buffy Coat Cells, Buccal Swab and Saliva Extracted DNA
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Extracted from the scope document; tables may not line up. View scope for the original.

For the tests to which this accreditation applies, please refer to the laboratory’s «field» Scope of Accreditation. Accredited Laboratory A2LA has accredited QUANTIGEN Fishers, IN for technical competence in the field of Clinical This laboratory is accredited in accordance with the recognized International Standard ISO 15189:2022 Medical laboratories - Requirements for quality and competence. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint IAF-ILAC-ISO Communiqué dated November 2021). Presented this 2nd day of March 2026. _______________________ Mr. Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 4842.01 Valid to April 30, 2028

Ranges are reproduced from the accredited scope document as published, and only where we found that range printed in the document for the line. Otherwise the cell reads “See scope document”. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.

Location

10300 Kincaid Dr, Suite 200, Fishers, IN, 43067, US

39.95559, -86.01387

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Accreditation data refreshed from the A2LA register on .

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