ABOUT US
Embryotech Laboratories is an ISO-17025 accredited test laboratory and Good Laboratory Practice for Nonclinical Laboratory Studies, Title 21 CFR Part 58 Accreditation Program. Embryotech Laboratories provides services to the assisted reproductive technologies industry and laboratories, providing the latest quality control assays. Embryotech Laboratories scope of accreditation includes toxicity and functionality testing of raw materials, media, and devices intended for use in the medical industry and/or any device which may come into contact with gametes — utilizing the following test or measurements: Mouse Embryo Assay (MEA): 1-cell and 2-cell method, Mouse Embryo Assay (MEA) Invitro-Fertilization, Human Sperm Survival Assay (HSSA), Sperm Motility Index (SM), Sperm Penetration Assay (SPA) and Human Sperm Motility Assay (SMA) utilizing Computer Assisted Sperm Analysis (CASA) software.
Embryotech Laboratories also offers endotoxin testing via Limulus Amebocyte Lysate Assay (LAL test) utilizing: Kinetic Turbidimetric quantitative and Gel-Clot qualitative testing. Additionally, we offer Bioburden testing to detect aerobic/anaerobic bacteria and fungi.
Also, we are the leader in supplying all stages of fresh and cryopreserved mouse embryos as well as hamster ova to clinics and universities around the world.
MISSION & VALUES
Embryotech is committed to continual improvement of processes and services to achieve ongoing customer satisfaction. It is, therefore, our policy to:
- Commit to good professional practices and to the quality of testing in servicing customers.
- Consistently provide quality testing services that meet or exceed customer and regulatory requirements.
- Ensure that all personnel concerned with testing activities within the laboratory familiarize themselves with the quality system documentation and implement the policies and procedures in their work.
- Consistently comply with ISO 17025 to ensure quality testing services and to continually improve the effectiveness of the management system.
- Foster a team environment where quality is everyone’s responsibility.
Embryotech senior management and all its employees are committed to this policy and are encouraged to participate in quality planning and continual improvement efforts to meet all quality, service and cost objectives.
CERTIFICATIONS
As the acknowledged leader in providing Quality Control testing to the Assisted Reproductive Technologies community, Embryotech Laboratories scope of accreditation includes Raw Materials, Media, and Deices intended for use in the Medical Industry, using the following test or measurements:
- Mouse Embryo Assay (MEA) 1-Cell Method
- Mouse Embryo Assay (MEA) 2-Cell Method
- Mouse Embryo Assay (MEA) Invitro-Fertilization
- Bioburden Testing – Medical Devices
- Sperm Motility Index (SM)
- Sperm Penetration Assay (SPA)
- Human Sperm Survival Assay (HSSA)
- Computer Assisted Sperm Analysis (CASA)
- Endotoxin (LAL) Gel-Clot Method
- Endotoxin (LAL) Kinetic Method
- pH (pH)
- Osmolarity (OSMO)
FLEXIBLE HOURS, FAST RESULTS
Embryotech takes pride in our facility – designed and built specifically to produce the highest quality products and services to the Assisted Reproductive Technologies.
Embryotech operates seven days per week following strict guidelines within ISO-17025. The flexible schedule offers an immediate turnaround time of 5-7 business days from test article receipt to reporting results. The animal facility is a perfect complement to our laboratory. The combined effort and watchful eyes of Embryotech’s staff veterinarian and the Institutional Animal Care and Use Committee (IACUC) assure that the embryos used for testing your products are the highest quality.