| Size | Catalog Id | Availability |
|---|---|---|
| 50 mL | CCD1-050 | In Stock |
| Available for sale in the USA, Canada, and select countries. | ||
CaseBio™ Handling
Product Description:
CaseBio™ Handling is a specialized solution designed for use in assisted reproductive technology (ART) procedures to support the short-term handling and manipulation of gametes and embryos. CaseBio™ Handling must be supplemented with human serum albumin (HSA) or another appropriate protein prior to use, according to standard laboratory procedures. The formulation contains a low concentration of sodium bicarbonate and should not be gassed with or used for culture under CO₂. It includes Gentamicin for antimicrobial protection and does not contain a protein supplement.
Intended Use
CaseBio™ Handling is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavity.
Key Features
-
High-quality, medical-grade raw materials screened for every incoming batch
Traceability and documentation maintained from source to final product
-
Triple QC testing on each lot
Stringent quality control to include pH, osmolality, endotoxin LAL, sterility, and One-Cell MEA with ≥80% embryos developed to expanded blastocysts at 120 hours.
-
Sterile filtered and sterility tested in compliance with USP<71> standards
-
Manufactured under a strict Quality Management System (ISO 13485:2016 certified manufacturer)
Quality system aligned with international standards for medical device manufacturing
-
FDA-registered manufacturing facility
-
MDSAP certified
Certified to meet regulatory requirements across multiple global markets
-
Reliable batch-to-batch consistency through rigorous quality control system and controlled processes
Controlled processes ensure reproducibility and dependable results. Certificates of Analysis provided with every lot.
Specifications:
| Product Line | CaseBio™ |
| Indications for Use/Intended Use | CaseBio™ Handling is intended for use in short-term handling and manipulating gametes and embryos, including washing and intracytoplasmic sperm injection (ICSI). This medium is not intended for transferring embryos to the uterine cavity. |
| Classification | Class II medical device, FDA-cleared and registered with Health Canada |
| Form | Liquid |
| Shelf Life | 90 days from date of manufacture |
| Sterility | Sterile-filtered |
| Storage Conditions | 2-8°C. Protect from light |
| Shipping Condition | Cold Chain |
| Manufacturing Quality | ISO 13485:2016 certified and aligned with international standards for medical device manufacturing |
