V-Hyadase
V-HYADASE is an assisted reproduction medium used to remove the cumulus and corona radiata cells surrounding an oocyte before intracytoplasmic sperm injection. It prepares the oocyte for…
V-HYADASE is an assisted reproduction medium used to remove the cumulus and corona radiata cells surrounding an oocyte before intracytoplasmic sperm injection. It prepares the oocyte for that procedure through enzymatic cell removal. It is a prescription laboratory medium.
The ready-to-use formulation contains bovine-source hyaluronidase in a HEPES-buffered medium with human serum albumin. The enzyme provides the cell-removal action. The formulation also contains physiological salts, glucose, amino acids and other medium constituents.
Listed Item
V-HYADASE is a ready-to-use media for the denudation of oocytes prior to the intracytoplasmic sperm injection (ICSI). It contains Hyaluronidase in HEPES buffered Human Tubal Fluid (HTF) Medium with Human Serum Albumin (HSA).
Container and Storage
The medium is aseptically filtered and filled as 1 mL in a presterilized 2 mL polypropylene copolymer bottle. It is stored at 2 to 8°C and may be used for up to seven days after the bottle is opened.
Who Else Makes It
Concentrated in Guangdong (3), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Gimbo Medical Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Shandong Wego Ruisheng Medical Device Co., Ltd. | Weihai | Shandong | Manufacturer | 2 |
Record
| Listed by | Vitromed GmbH, Germany |
|---|---|
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K222606 |
| Record published | 2023-07-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V-HYA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LifeGlobal® Media | LifeGlobal Group, LLC | 93 |
| Sydney IVF | William A. Cook Australia PTY, Ltd. | 29 |
| LifeGlobal® Media | Coopersurgical, Inc. | 27 |
| VitaVitro | Shenzhen VitaVitro Biotech Co., Ltd. | 22 |
| Nidacon | Nidacon International AB | 19 |
| Sil-Select Plus Lower Layer | Fertipro NV | 8 |
| FertiCult Mineral Oil | Fertipro NV | 8 |
| Dewin | Donnevie Medical Technology (Shanghai) Co., Ltd. | 8 |
| SpermGrad | Vitrolife Sweden AB | 8 |
| Sequential Culture Media | Kitazato Corporation | 8 |
| Sperm Wash Medium | Invitrocare Inc | 7 |
| Enhance-S Plus | Vitrolife Inc. | 7 |
Showing 12 of 360. All products under Media, Reproductive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241833 | 2025-03-21 |
| K240176 | 2024-09-13 |
| K232125 | 2024-03-20 |
| K222606 | 2023-05-26 |
| K223117 | 2023-01-31 |
| K193285 | 2020-11-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.