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United States

Element Materials Technology

2341 Stanwell Drive, 94520, Concord, CA, United States

A2LA|3383.01A2LA|3383.03ISO/IEC 17025Register refreshed 2026-09-25
Certificates
2
Scope items
6
Standards
22
Locations
3
One of 3 locations. View the organization

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Register record

A2LARefreshed
3383.01Active
3383.03Active

Accredited standards

22

Our reading of the A2LA scope: each standard once, with its official name where we have checked it. Click a standard to see the scope line it comes from, word for word.

USP

USP 51Name not checked yet
As written on the certificate · Line 1 (A2LA 3383.03)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

As written on the certificate · Line 1 (A2LA 3383.01)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

USP 55Name not checked yet
As written on the certificate · Line 1 (A2LA 3383.03)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

As written on the certificate · Line 1 (A2LA 3383.01)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

USP 60Name not checked yet
As written on the certificate · Line 2 (A2LA 3383.03)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

As written on the certificate · Line 2 (A2LA 3383.01)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

USP 61Name not checked yet
As written on the certificate · Line 2 (A2LA 3383.03)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

As written on the certificate · Line 2 (A2LA 3383.01)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

USP 62Name not checked yet
As written on the certificate · Line 2 (A2LA 3383.03)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

As written on the certificate · Line 2 (A2LA 3383.01)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

USP 63Name not checked yet
As written on the certificate · Line 2 (A2LA 3383.03)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

As written on the certificate · Line 2 (A2LA 3383.01)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

USP 71Name not checked yet
As written on the certificate · Line 2 (A2LA 3383.03)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

As written on the certificate · Line 2 (A2LA 3383.01)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

USP 85Name not checked yet
As written on the certificate · Line 1 (A2LA 3383.03)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

As written on the certificate · Line 1 (A2LA 3383.01)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

USP 87Name not checked yet
As written on the certificate · Line 1 (A2LA 3383.03)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

As written on the certificate · Line 1 (A2LA 3383.01)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

USP 797Name not checked yet
As written on the certificate · Line 1 (A2LA 3383.03)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

As written on the certificate · Line 2 (A2LA 3383.03)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

As written on the certificate · Line 1 (A2LA 3383.01)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

As written on the certificate · Line 2 (A2LA 3383.01)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

USP 1050Name not checked yet
As written on the certificate · Line 1 (A2LA 3383.03)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

As written on the certificate · Line 1 (A2LA 3383.01)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

USP 1113Name not checked yet
As written on the certificate · Line 2 (A2LA 3383.03)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

As written on the certificate · Line 2 (A2LA 3383.01)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

USP 1116Name not checked yet
As written on the certificate · Line 1 (A2LA 3383.03)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

As written on the certificate · Line 2 (A2LA 3383.03)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

As written on the certificate · Line 1 (A2LA 3383.01)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

As written on the certificate · Line 2 (A2LA 3383.01)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

USP 1231Name not checked yet
As written on the certificate · Line 2 (A2LA 3383.03)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

As written on the certificate · Line 2 (A2LA 3383.01)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

USP 1237Name not checked yet
As written on the certificate · Line 1 (A2LA 3383.03)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

As written on the certificate · Line 1 (A2LA 3383.01)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

USP 2021Name not checked yet
As written on the certificate · Line 2 (A2LA 3383.03)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

As written on the certificate · Line 2 (A2LA 3383.01)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

ISO

ISO 8573Name not checked yet
As written on the certificate · Line 1 (A2LA 3383.03)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

As written on the certificate · Line 1 (A2LA 3383.01)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

ISO 10993-5Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
As written on the certificate · Line 1 (A2LA 3383.03)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

As written on the certificate · Line 1 (A2LA 3383.01)

USP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>

ISO 11737-1Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
As written on the certificate · Line 2 (A2LA 3383.03)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

As written on the certificate · Line 2 (A2LA 3383.01)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

ISO 14644-1Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
As written on the certificate · Line 2 (A2LA 3383.03)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

As written on the certificate · Line 2 (A2LA 3383.01)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

ISO 14644-2Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
As written on the certificate · Line 2 (A2LA 3383.03)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

As written on the certificate · Line 2 (A2LA 3383.01)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

Other standards

EPA 1604Name not checked yet
As written on the certificate · Line 2 (A2LA 3383.03)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

As written on the certificate · Line 2 (A2LA 3383.01)

USP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604

Scope as published by A2LA

6 lines
A2LA

ISO/IEC 17025

Active

3383.01

The scope document we hold says it is valid until 2026-12-31.

View scope

Accredited scope, certificate 3383.01

LineDisciplineMethodMatrixRange
1biologicalUSP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>Pharmaceuticals-
2biologicalUSP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604Non-Sterile Products; Water Systems-
3biological
For the tests to which this accreditation applies, please refer to the laboratory’s Biological Scope of Accreditation. Accredited Laboratory A2LA has accredited ELEMENT MATERIALS TECHNOLOGY Concord, CA for technical competence in the field of Biological Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017). Presented this 24th day of February, 2025. _______________________ Mr. Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 3383.01 Valid to December 31, 2026

Ranges are reproduced from the accredited scope document as published. 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.

A2LA

ISO/IEC 17025

Active

3383.03

The scope document we hold says it is valid until 2026-12-31.

View scope

Accredited scope, certificate 3383.03

LineDisciplineMethodMatrixRange
1biologicalUSP <51>; USP <85>; USP <55>; USP <797>; USP <1116>; ISO 8573; ISO 10993-5; USP <87>; EU 2.6.7; USP <1050>; USP <1237>Pharmaceuticals-
2biologicalUSP <797>; USP <1116>; ISO 14644-1; ISO 14644-2; USP <61>; USP <62>; USP <71>; USP <2021>; USP <1113>; ISO 11737; USP <60>; USP <62>; USP <63>; EP 2.6.7; USP <1231>; EPA 1604Non-Sterile Products; Water Systems-
3biological
For the tests to which this accreditation applies, please refer to the laboratory’s Biological Scope of Accreditation. Accredited Laboratory A2LA has accredited ELEMENT MATERIALS TECHNOLOGY Concord, CA for technical competence in the field of Biological Testing This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories. This accreditation demonstrates technical competence for a defined scope and the operation of a laboratory quality management system (refer to joint ISO-ILAC-IAF Communiqué dated April 2017). Presented this 24th day of February, 2025. _______________________ Mr. Trace McInturff, Vice President, Accreditation Services For the Accreditation Council Certificate Number 3383.01 Valid to December 31, 2026

Ranges are reproduced from the accredited scope document as published. 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

2341 Stanwell Drive, Concord, CA, 94520, US

37.97685, -122.03356

Open in Maps

Other Locations

2 other sites in this organization

Minnetonka, MN, US
View
Piedmont, SC, US
View
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