FDA UDI
In Commercial Distribution
🇺🇸 United States
VitalScreen
DI: 05411967000043
·
Model: VITAL
·
Fertipro NV
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VitalScreen
- Primary DI
- 05411967000043
- Version / Model
- VITAL
- Company Name
- Fertipro NV
- Labeler DUNS
- 373904101
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-22
- Public Version
- 3
- Public Version Date
- 2021-01-29
- Public Version Status
- Update
- Public Device Record Key
- 443b5b01-2a54-4719-a398-3829a36d7f30
Device Description
VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm vitality by dye exclusion. The kit consist of 20ml of 1% Eosin Y in saline (product code: VITAL_1 and 30ml of 5% Nigrosin in saline (product code: VITAL_2). The eosin-nigrosin staining technique is based on the principle that dead cells will take up the eosin and as a result stain red. The nigrosin provides a dark background which makes it easier to assess the slides. The VitalScreen™ is based on the test procedure described in the WHO laboratory manual (2010). VitalScreen™ has a 24 month shelf life from date of produce. Reference is made to the product page of VitalScreen on the FertiPro website: www.fertipro.com
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| LED | Stains, Chemical Solution | Hematology | 864.1850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43587 | Biological stain IVD | A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05411967000043 | GS1 |
Customer Contacts
- Phone
- +3250791805
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius