HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in…
HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn metal (Quinn P, Kerin JF, Warnes GM:Fertil Steril 1985;44:493-498). HTF HEPES uses a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere.
Who Else Makes It
Concentrated in Guangdong (3), Shandong (1).
Record
Regulatory record for HTF Hepes | 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) | K000939 |
| 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.