InVitroCare's HYALURONIDASE reagent is composed of Bovine Testes Hyaluronidase (Sigma Catalog #H4272) dissolved in a combined sodium bicarbonate/HEPES…
InVitroCare’s HYALURONIDASE reagent is composed of Bovine Testes Hyaluronidase (Sigma Catalog #H4272) dissolved in a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system at a concentration of 100units/ml and is appropriate for those procedures that do not use a carbon dioxide atmosphere. HYALURONIDASE reagent is intended for use prior to intracytoplasmic sperm injection (ICSI) procedures to digest the Hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.
Who Else Makes It
Concentrated in Guangdong (3), Shandong (1).
Record
Regulatory record for Hyaluronidase | Listed by | Invitrocare Inc, United States |
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K003751 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
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.