Origio Gradient 40/80
ORIGIO Gradient 40/80 is a laboratory medium for separating motile sperm from an ejaculate by a density gradient method. The gradient solutions have different densities and contain silane…
ORIGIO Gradient 40/80 is a laboratory medium for separating motile sperm from an ejaculate by a density gradient method. The gradient solutions have different densities and contain silane silica, which provides the density used in this separation process. They are intended for sperm preparation and handling.
The 40 and 80 formulations are colourless, viscous solutions supplied in bottles. Both contain human serum albumin and gentamicin. Their different silica and salt concentrations provide distinct density characteristics, allowing them to serve as the respective gradient media in the preparation procedure.
Listed Item
ORIGIO Gradient 40/80 12 x 10 ml
Preparation and Packaging
The solutions are manufactured using aseptic filtration and are supplied in transparent PETG bottles with HDPE closures. Instructions accompany the packaged media, including the conditions required for storage and use after opening.
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 | Origio A/S, Denmark |
|---|---|
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K153267 |
| Record published | 2018-04-18 |
| Record revised | 2018-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Special storage condition: Protect from light |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 84022010D | In distribution | |
| 84021210D | In distribution | |
| 84022060D | 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 |
|---|---|
| K173624 | 2018-03-02 |
| K172197 | 2017-10-13 |
| K153267 | 2016-07-22 |
| K152932 | 2016-02-29 |
| K140317 | 2014-06-16 |
| K133912 | 2014-05-14 |
| K133387 | 2014-04-29 |
| K133707 | 2014-04-16 |
| K120136 | 2012-09-26 |
| K100367 | 2010-08-27 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | 510(k) number | 2024-02-16 | Class II | Under Investigation by firm | Low concentration of sodium pyruvate in the wash could compromise gamete development | 980 units |
| Coopersurgical, Inc. | 510(k) number | 2024-02-16 | Class II | Under Investigation by firm | Low concentration of sodium pyruvate in the wash could compromise gamete development | 2680 units |
| Coopersurgical, Inc. | 510(k) number | 2024-02-16 | Class II | Under Investigation by firm | Low concentration of sodium pyruvate in the wash could compromise gamete development | 770 units |
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.