Microbac Laboratories, Inc.
105 Carpenter Drive, 20164, Sterling, VA, United States
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Register record
- A2LARefreshed
- 3376.01Active
Accredited standards
22Our 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.
EN
EN 1040Name not checked yet
ICH Q5A Sept. 1999; FDA-PTC mAb for Human Use; EMEA-CHMP-BWP 398498 (July 2008); ISO 22442-3 (2007) LU Reference; AATCC100; JIS L1902; EN 1040:2005; EN 1275:2005; ISO 23409 Annex G; ISO 25841 Annex G; FDA CDRH Guidance, June 29, 1995; Chapter 1072 of the US Pharmacopeia; FDA (1993), “Guide to Inspections Validation of Cleaning Processes” <USP 1072>
EN 1275Name not checked yet
ICH Q5A Sept. 1999; FDA-PTC mAb for Human Use; EMEA-CHMP-BWP 398498 (July 2008); ISO 22442-3 (2007) LU Reference; AATCC100; JIS L1902; EN 1040:2005; EN 1275:2005; ISO 23409 Annex G; ISO 25841 Annex G; FDA CDRH Guidance, June 29, 1995; Chapter 1072 of the US Pharmacopeia; FDA (1993), “Guide to Inspections Validation of Cleaning Processes” <USP 1072>
EN 13610Name not checked yet
ASTM E1054; ASTM E1153; ASTM 1174; ISO 21702; CLSI- M07; ASTM E1173; I.S. EN 13697:2015+A1(2019) E; EN 16777; EN 14675; PAS 2424; BS EN 13727:2012+A2:2015; BS EN 13624:2013; EN 13610; ASTM E1115; ISO 18184; FDA CDRH “Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers (March 12, 2000)”
EN 13624Name not checked yet
ASTM E1054; ASTM E1153; ASTM 1174; ISO 21702; CLSI- M07; ASTM E1173; I.S. EN 13697:2015+A1(2019) E; EN 16777; EN 14675; PAS 2424; BS EN 13727:2012+A2:2015; BS EN 13624:2013; EN 13610; ASTM E1115; ISO 18184; FDA CDRH “Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers (March 12, 2000)”
EN 13697Name not checked yet
ASTM E1054; ASTM E1153; ASTM 1174; ISO 21702; CLSI- M07; ASTM E1173; I.S. EN 13697:2015+A1(2019) E; EN 16777; EN 14675; PAS 2424; BS EN 13727:2012+A2:2015; BS EN 13624:2013; EN 13610; ASTM E1115; ISO 18184; FDA CDRH “Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers (March 12, 2000)”
EN 13727Name not checked yet
ASTM E1054; ASTM E1153; ASTM 1174; ISO 21702; CLSI- M07; ASTM E1173; I.S. EN 13697:2015+A1(2019) E; EN 16777; EN 14675; PAS 2424; BS EN 13727:2012+A2:2015; BS EN 13624:2013; EN 13610; ASTM E1115; ISO 18184; FDA CDRH “Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers (March 12, 2000)”
EN 14476Name not checked yet
ICH Q5A Sept 1999; FDA-PTC mAb for Human Use; EMEA-CHMP-BWP 398498 (July 2008); ISO 22442-3 (2007); ASTM E1053; EN 14476; ASTM E1052
EN 14675Name not checked yet
ASTM E1054; ASTM E1153; ASTM 1174; ISO 21702; CLSI- M07; ASTM E1173; I.S. EN 13697:2015+A1(2019) E; EN 16777; EN 14675; PAS 2424; BS EN 13727:2012+A2:2015; BS EN 13624:2013; EN 13610; ASTM E1115; ISO 18184; FDA CDRH “Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers (March 12, 2000)”
EN 16777Name not checked yet
ASTM E1054; ASTM E1153; ASTM 1174; ISO 21702; CLSI- M07; ASTM E1173; I.S. EN 13697:2015+A1(2019) E; EN 16777; EN 14675; PAS 2424; BS EN 13727:2012+A2:2015; BS EN 13624:2013; EN 13610; ASTM E1115; ISO 18184; FDA CDRH “Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers (March 12, 2000)”
ASTM
ASTM E1052Name not checked yet
ICH Q5A Sept 1999; FDA-PTC mAb for Human Use; EMEA-CHMP-BWP 398498 (July 2008); ISO 22442-3 (2007); ASTM E1053; EN 14476; ASTM E1052
ASTM E1053Name not checked yet
ICH Q5A Sept 1999; FDA-PTC mAb for Human Use; EMEA-CHMP-BWP 398498 (July 2008); ISO 22442-3 (2007); ASTM E1053; EN 14476; ASTM E1052
ASTM E1054Name not checked yet
ASTM E1054; ASTM E1153; ASTM 1174; ISO 21702; CLSI- M07; ASTM E1173; I.S. EN 13697:2015+A1(2019) E; EN 16777; EN 14675; PAS 2424; BS EN 13727:2012+A2:2015; BS EN 13624:2013; EN 13610; ASTM E1115; ISO 18184; FDA CDRH “Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers (March 12, 2000)”
ASTM E1115Name not checked yet
ASTM E1054; ASTM E1153; ASTM 1174; ISO 21702; CLSI- M07; ASTM E1173; I.S. EN 13697:2015+A1(2019) E; EN 16777; EN 14675; PAS 2424; BS EN 13727:2012+A2:2015; BS EN 13624:2013; EN 13610; ASTM E1115; ISO 18184; FDA CDRH “Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers (March 12, 2000)”
ASTM E1153Name not checked yet
ASTM E1054; ASTM E1153; ASTM 1174; ISO 21702; CLSI- M07; ASTM E1173; I.S. EN 13697:2015+A1(2019) E; EN 16777; EN 14675; PAS 2424; BS EN 13727:2012+A2:2015; BS EN 13624:2013; EN 13610; ASTM E1115; ISO 18184; FDA CDRH “Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers (March 12, 2000)”
ASTM E1173Name not checked yet
ASTM E1054; ASTM E1153; ASTM 1174; ISO 21702; CLSI- M07; ASTM E1173; I.S. EN 13697:2015+A1(2019) E; EN 16777; EN 14675; PAS 2424; BS EN 13727:2012+A2:2015; BS EN 13624:2013; EN 13610; ASTM E1115; ISO 18184; FDA CDRH “Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers (March 12, 2000)”
ISO
ISO 18184Textiles - Determination of antiviral activity of textile products
ASTM E1054; ASTM E1153; ASTM 1174; ISO 21702; CLSI- M07; ASTM E1173; I.S. EN 13697:2015+A1(2019) E; EN 16777; EN 14675; PAS 2424; BS EN 13727:2012+A2:2015; BS EN 13624:2013; EN 13610; ASTM E1115; ISO 18184; FDA CDRH “Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers (March 12, 2000)”
ISO 21702Measurement of antiviral activity on plastics and other non-porous surfaces
ASTM E1054; ASTM E1153; ASTM 1174; ISO 21702; CLSI- M07; ASTM E1173; I.S. EN 13697:2015+A1(2019) E; EN 16777; EN 14675; PAS 2424; BS EN 13727:2012+A2:2015; BS EN 13624:2013; EN 13610; ASTM E1115; ISO 18184; FDA CDRH “Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers (March 12, 2000)”
ISO 22442-3Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
ICH Q5A Sept. 1999; FDA-PTC mAb for Human Use; EMEA-CHMP-BWP 398498 (July 2008); ISO 22442-3 (2007) LU Reference; AATCC100; JIS L1902; EN 1040:2005; EN 1275:2005; ISO 23409 Annex G; ISO 25841 Annex G; FDA CDRH Guidance, June 29, 1995; Chapter 1072 of the US Pharmacopeia; FDA (1993), “Guide to Inspections Validation of Cleaning Processes” <USP 1072>
ICH Q5A Sept 1999; FDA-PTC mAb for Human Use; EMEA-CHMP-BWP 398498 (July 2008); ISO 22442-3 (2007); ASTM E1053; EN 14476; ASTM E1052
ISO 23409Male condoms - Requirements and test methods for condoms made from synthetic materials
ICH Q5A Sept. 1999; FDA-PTC mAb for Human Use; EMEA-CHMP-BWP 398498 (July 2008); ISO 22442-3 (2007) LU Reference; AATCC100; JIS L1902; EN 1040:2005; EN 1275:2005; ISO 23409 Annex G; ISO 25841 Annex G; FDA CDRH Guidance, June 29, 1995; Chapter 1072 of the US Pharmacopeia; FDA (1993), “Guide to Inspections Validation of Cleaning Processes” <USP 1072>
ISO 25841Female condoms - Requirements and test methods
ICH Q5A Sept. 1999; FDA-PTC mAb for Human Use; EMEA-CHMP-BWP 398498 (July 2008); ISO 22442-3 (2007) LU Reference; AATCC100; JIS L1902; EN 1040:2005; EN 1275:2005; ISO 23409 Annex G; ISO 25841 Annex G; FDA CDRH Guidance, June 29, 1995; Chapter 1072 of the US Pharmacopeia; FDA (1993), “Guide to Inspections Validation of Cleaning Processes” <USP 1072>
Other standards
AATCC 100Name not checked yet
ICH Q5A Sept. 1999; FDA-PTC mAb for Human Use; EMEA-CHMP-BWP 398498 (July 2008); ISO 22442-3 (2007) LU Reference; AATCC100; JIS L1902; EN 1040:2005; EN 1275:2005; ISO 23409 Annex G; ISO 25841 Annex G; FDA CDRH Guidance, June 29, 1995; Chapter 1072 of the US Pharmacopeia; FDA (1993), “Guide to Inspections Validation of Cleaning Processes” <USP 1072>
USP 1072Name not checked yet
ICH Q5A Sept. 1999; FDA-PTC mAb for Human Use; EMEA-CHMP-BWP 398498 (July 2008); ISO 22442-3 (2007) LU Reference; AATCC100; JIS L1902; EN 1040:2005; EN 1275:2005; ISO 23409 Annex G; ISO 25841 Annex G; FDA CDRH Guidance, June 29, 1995; Chapter 1072 of the US Pharmacopeia; FDA (1993), “Guide to Inspections Validation of Cleaning Processes” <USP 1072>
Scope as published by A2LA
4 lines
ISO/IEC 17025
Active3376.01
The scope document we hold says it is valid until 2027-01-31.
Accredited scope, certificate 3376.01
| Line | Discipline | Method | Matrix | Range |
|---|---|---|---|---|
| 1 | biological | ICH Q5A Sept. 1999; FDA-PTC mAb for Human Use; EMEA-CHMP-BWP 398498 (July 2008); ISO 22442-3 (2007) LU Reference; AATCC100; JIS L1902; EN 1040:2005; EN 1275:2005; ISO 23409 Annex G; ISO 25841 Annex G; FDA CDRH Guidance, June 29, 1995; Chapter 1072 of the US Pharmacopeia; FDA (1993), “Guide to Inspections Validation of Cleaning Processes” <USP 1072> | suspensions, and hard and soft surfaces | - |
| 2 | biological | ASTM E1054; ASTM E1153; ASTM 1174; ISO 21702; CLSI- M07; ASTM E1173; I.S. EN 13697:2015+A1(2019) E; EN 16777; EN 14675; PAS 2424; BS EN 13727:2012+A2:2015; BS EN 13624:2013; EN 13610; ASTM E1115; ISO 18184; FDA CDRH “Guidance for Manufacturers Seeking Marketing Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers (March 12, 2000)” | - | - |
| 3 | biological | ICH Q5A Sept 1999; FDA-PTC mAb for Human Use; EMEA-CHMP-BWP 398498 (July 2008); ISO 22442-3 (2007); ASTM E1053; EN 14476; ASTM E1052 | - | - |
| 4 | biological | For the tests to which this accreditation applies, please refer to the laboratory’s Biological Scope of Accreditation.
Accredited Laboratory
A2LA has accredited
MICROBAC LABORATORIES, INC.
Sterling, VA
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 21st day of January 2025.
_______________________
Mr. Trace McInturff, Vice President, Accreditation Services
For the Accreditation Council
Certificate Number 3376.01
Valid to January 31, 2027 | ||
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
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2 other sites in this organization
Accreditation data refreshed from the A2LA register on .
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