FDA UDI
In Commercial Distribution
🇺🇸 United States
HOS Test
DI: 05411967001873
·
Model: HOST
·
Fertipro NV
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HOS Test
- Primary DI
- 05411967001873
- Version / Model
- HOST
- Company Name
- Fertipro NV
- Labeler DUNS
- 373904101
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-16
- Public Version
- 2
- Public Version Date
- 2023-04-28
- Public Version Status
- Update
- Public Device Record Key
- 25a43ed8-3ada-41f6-b11f-35de07350f77
Device Description
Sperm vitality test The hypo-osmotic swelling test is a sperm vitality test based on the principle that live spermatozoa swell due to the absorption of a hypo-osmotic solution. The HOS test is based on the test procedure described in the WHO laboratory manual for the examination of human semen and sperm-cervical mucus interaction. For more information, visit the FertiPro website: www.fertipro.com
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PPM | General Purpose Reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52887 | Osmolality IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of osmolality of a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05411967000050 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 05411967001873 | GS1 |
Customer Contacts
- Phone
- +3250791805
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 20 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius