SPERM WASH MEDIUM for Swim-Up is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It…
SPERM WASH MEDIUM for Swim-Up is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is 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 etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM for Swim-Up 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 Sperm Wash Medium for Swim-Up | 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) | K000989 |
| 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.