Reagecon Diagnostics Ltd.

Shannon Free Zone, Shannon, Clare, V14 X073

Calibration Laboratory

Registration number: 265C

is accredited by the Irish National Accreditation Board (INAB) to undertake calibration as detailed in the scope bearing the registration number detailed

above, in conformity with ISO/IEC 17025:2017“General requirements for the competence of testing and calibration laboratories”

(This certificate must be read in conjunction with the publicly available scope of accreditation)

Date of award of accreditation: 12/07/2010Date of last renewal of accreditation: 14/07/2016

Expiry date of this certificate of accreditation:14/07/2021

This accreditation shall remain in force until further notice subject to continuing conformity with the above standard, applicable EA/ILAC requirements and any further requirements

specified by the Irish National Accreditation Board.

INAB Registration No. 265C Issue 2, 24/02/2020

Manager: Chairperson: : Dr Adrienne Duff Ms Ita Kinahan

Organisations are subject to annual surveillance and are re-assessed every five years. The renewal date on this certificate confirms the latest date of renewal of accreditation. To confirm the validity of this certificate, please

contact the Irish National Accreditation Board.INAB is a signatory of the European co-operation for Accreditation (EA) Multilateral Agreement (MLA) and the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement for Calibration.

The Metropolitan Building, James Joyce Street, Dublin 1, Ireland Tel: 1890 289 389. Int Tel: +353 1 614 7000. Email: inab@inab.ie Web: www.inab.ie

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INAB Registration No. 265C

Schedule of Accreditation

Organisation Name

Reagecon Diagnostics Ltd.

Trading As

INAB Reg No

265C

Contact Name

Dean Meagher

Address

Shannon Free Zone, Shannon, Clare, V14 X073

Contact Phone No

Email

dean.meagher@reagecon.ie

Website

http://www.reagecon.com

Accreditation Standard

ISO 17025 C

Date Initially Awarded

12/07/2010

Scope Classification Metrology

Services available to the public¹

Yes

¹ Refer to document on interpreting INAB Scopes of Accreditation

Sites from which accredited services are delivered (the detail of the accredited services delivered at each site are on the Scope of Accreditation)

Name Address

1 Head Office Shannon Free Zone, Shannon, Clare, V14 X073

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INAB Registration No. 265C

Scope of Accreditation

Head Office

Metrology

Category: A

Metrology field - Calibrated Device Type

Measured quantity Calibration range Calibration and measurement capability (CMC)

Std. ref/SOP Products Remarks

104 Volume - .02 Special laboratory volumetric apparatus

N/A Single Channel: 5 to 10 μL 10 to 20 μL 20 to 100 μL 100 to 200 μL 200 to 500 μL 500 to 1000 μL 1000 to 2,000 μL 2,000 to 5,000 μL 5,000 to 10,000 μL

Single Channel: ±0.15 μL ±0.15 μL ±0.45 μL ±0.70 μL ±2.0 μL ±4.0 μL ±10 μL ±30 μL ±50 μL

CAL-TS 5,8,9,11,13, 14,15,20,22,23,31, 37 (A)(B), 39,40,41, 42,46,80,85,104

For water delivered from piston and/or plunger operated volumetric apparatus

107 Temperature measuring equipment - .09 Digital temperature indicator systems

- 45 °C to +140 °C 140 °C to 400 °C 400 °C to 650 °C

± 0.050 °C ± 0.13 °C ± 0.32 °C

CAL-TS 5,49,50,52, 53,62,63,64, 66,67,68,69 ,72,74,85,101, 104,112

113 Time - .99 Other Time interval 0 minutes to 24 hours

±0.60 seconds CAL-SW

* Notes: 1. In accordance with INAB policy, uncertainties are calculated for an estimated confidence level of not less than 95%. 2. Calibration and measurement capability expressed as an uncertainty (±) to be

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INAB Registration No. 265C

reported in compliance with EA-4/02, “Expression of the Uncertainty of Measurement in Calibration”. Calibration Measurement Capability (CMC) is expressed in terms of the following parameters: - Measurand or reference material - Calibration or measurement method or procedure and type of instrument or material calibrated/measured - Measurement range and additional parameters where applicable - Measurement uncertainty

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INAB Registration No. 265C

Head Office

Metrology

Category: B

Metrology field - Calibrated Device Type

Measured quantity Calibration range Calibration and measurement capability (CMC)

Std. ref/SOP Products Remarks

101 Mass - .01 Precision laboratory balances

N/A 1 mg to 5 g 5 g to 20 g 20 g to 100 g

±0.031 mg ±0.048 mg ±0.083 mg

Documented in-house methods: CAL-TS 8,9,11,14,15, 22,26,31, 32,37 (a) (b), 38,41, 85, 104, 108 Using OIML Class E2 from 1mg to 600g.

101 Mass - .02 Industrial balances

100 g to 200 g 200 g to 600 g

±0.16 mg ±0.26 mg

Documented in-house methods: CAL-TS 8,9,11,14,15, 22,26,31, 32,37 (a) (b), 38,41, 85, 104, 108 Using OIML Class E2 from 1mg to 600g.

101 Mass - .03 Industrial weighing appliances

100 g to 1 kg 1 kg to 2 kg 2 kg to 5 kg 5 kg to 10 kg 1 kg to 10 kg 10 kg to 20 kg 20 kg to 50 kg 50 kg to 100 kg 100 kg to 160 kg

±1.6 mg ±3.1 mg ±7.7 mg ±11 mg ±0.16 g ±0.31 g ±0.47 g ±0.69 g ±0.80 g

Documented in-house methods: CAL-TS 8,9,11,14,15,22,26, 31, 32,37 (a) (b), 38,41, 85, 104, 108. Using Class F1 from 100g to 5kg Using Class M1: 5 x 20kg and 6 x 10kg

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INAB Registration No. 265C

104 Volume - .02 Special laboratory volumetric apparatus

Single Channel: 5 to 10 μL 10 to 20 μL 20 to 100 μL 100 to 200 μL 200 to 300 μL 300 to 1,000 μL 1,000 to 2,000 μL 2,000 to 5,000 μL 5,000 to 10,000 μL

Single Channel: ±0.15 μL ±0.45 μL ±0.60 μL ±0.70 μL ±2.0 μL ±4.0 μL ±10 μL ±30 μL ±50 μL

CAL-TS 5,8,9,11,13,14, 15,20,22,23,31, 37 (A)(B), 39,40, 41,42,43, 46,80, 85,86,104

For water delivered from piston and/or plunger operated volumetric apparatus

108 Temperature controlled enclosures - .01 Ovens, furnaces, baths

-45 °C to + 140 °C ±0.17 °C CAL-TS 49,50,52,54,56, 57,58,59,60,61, 62,65,66,67,68, 69,72,74,75,76, 77,85,100,104

108 Temperature controlled enclosures - .02 Incubators

-45 °C to +140 °C ±0.17 °C

CAL-TS 49,50,52,54,56, 57,58,59,60,61, 62,65,66,67,68, 69,72,74,75,76, 77,85,100,104

108 Temperature controlled enclosures - .03 Autoclaves and sterilising ovens

80 °C to 140 °C ±0.32 °C CAL-TS 49,52,62,65, 66,67,68,69,72, 74,85,87a,87b, 101,102,104 CAL-SW

108 Temperature controlled enclosures - .04 Industrial freezers

-90 °C to -45 °C -45 °C to + 140 °C

±0.40 °C ±0.17 °C

CAL-TS 49,50,52,54,56, 57,58,59,60,61, 62,65,66,67,68, 69,72,74,75,76, 77,85,100,104

* Notes: 1. In accordance with INAB policy, uncertainties are calculated for an estimated confidence level of not less than 95%. 2. Calibration and measurement capability expressed as an uncertainty (±) to be reported in compliance with EA-4/02, “Expression of the Uncertainty of Measurement in Calibration”.

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INAB Registration No. 265C

Calibration Measurement Capability (CMC) is expressed in terms of the following parameters: - Measurand or reference material - Calibration or measurement method or procedure and type of instrument or material calibrated/measured - Measurement range and additional parameters where applicable - Measurement uncertainty