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United States

Quanterix Corporation

18 Crosby Drive, 01730, Bedford, MA, United States

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A2LA 6121.01ISO 15189Register refreshed 2026-11-06
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Scope lines
2
A2LA certificate
1
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2
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.

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A2LA certificate 6121.01 · 2 lines

LineMethodMatrixRange
1-Serum (S); Plasma (P)
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Extracted from the scope document; tables may not line up. View scope for the original.

(A2LA Cert. No. 6121.01) Revised 01/14/2026 Page 1 of 1 SCOPE OF ACCREDITATION TO ISO 15189:2022 QUANTERIX CORPORATION 18 Crosby Drive Bedford, MA 01730 Mark Schwerzler Phone: 781-412-5319 CLINICAL Valid To: July 31, 2027 Certificate Number: 6121.01 In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following types of testing on human samples, including: Serum (S) and Plasma (P). Specialty Sub Specialty Test/Analyte Method Matrix Chemistry Routine Chemistry LucentAD Complete Simoa Bead Technology P Neurofilament-Light (NfL) Simoa Bead Technology S pTau-181 Simoa Bead Technology P pTau-217 Simoa Bead Technology P pTau-217 QL Simoa Bead Technology P
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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 QUANTERIX CORPORATION Bedford, MA 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 19th day of June 2025. _______________________ Mr. Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 6121.01 Valid to July 31,2027

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

18 Crosby Drive, Bedford, MA, 01730, US

42.49173, -71.28179

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Other Locations

1 other site in this organization

Billerica, MA, US
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