| Size | Catalog Id | Availability |
|---|---|---|
| 100 mL | HTFC-100 | In Stock |
| Available for sale in the USA, Canada, and select countries. | ||
CaseBio® HTF
Product Description:
CaseBio® HTF is a bicarbonate-buffered medium designed for human embryo culture. For use, it must be supplemented with human serum albumin or another suitable protein in accordance with standard laboratory procedures. CaseBio® HTF should be maintained under a controlled CO₂ atmosphere to support stable pH and reliable embryo culture conditions. Contains Gentamicin. Does not include Protein Supplement.
CaseBio® HTF contains Gentamicin.
Intended Use
CaseBio® HTF is used for the culture of embryos to the cleavage stage (Day 3).
This device can be used for transfer of embryos to the uterus.
Key Features
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High-quality, medical-grade raw materials screened for every incoming batch
Traceability and documentation maintained from source to final product
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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.
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Sterile filtered and sterility tested in compliance with USP<71> standards
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Manufactured under a strict Quality Management System (ISO 13485:2016 certified manufacturer)
Quality system aligned with international standards for medical device manufacturing
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FDA-registered manufacturing facility
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MDSAP certified
Certified to meet regulatory requirements across multiple global markets
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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® HTF is used for the culture of embryos to the cleavage stage (Day 3). This device can be used for transfer of embryos to the uterus. |
| 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 |
