VitalScreen
GUDID 05411967000043
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
Fertipro NV
Biological stain kit IVD| Primary Device ID | 05411967000043 |
| NIH Device Record Key | 443b5b01-2a54-4719-a398-3829a36d7f30 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VitalScreen |
| Version Model Number | VITAL |
| Company DUNS | 373904101 |
| Company Name | Fertipro NV |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +3250791805 |
| info@fertipro.com | |
| Phone | +3250791805 |
| info@fertipro.com | |
| Phone | +3250791805 |
| info@fertipro.com | |
| Phone | +3250791805 |
| info@fertipro.com | |
| Phone | +3250791805 |
| info@fertipro.com | |
| Phone | +3250791805 |
| info@fertipro.com | |
| Phone | +3250791805 |
| info@fertipro.com | |
| Phone | +3250791805 |
| info@fertipro.com | |
| Phone | +3250791805 |
| info@fertipro.com | |
| Phone | +3250791805 |
| info@fertipro.com | |
| Phone | +3250791805 |
| info@fertipro.com | |
| Phone | +3250791805 |
| info@fertipro.com | |
| Phone | +3250791805 |
| info@fertipro.com | |
| Phone | +3250791805 |
| info@fertipro.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05411967000043 [Primary] |
FDA Product Code
| LED | Stains, Chemical Solution |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-10 |
| Device Publish Date | 2018-08-22 |
On-Brand Devices [VitalScreen]
| 54119670000430 | VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm |
| 05411967000043 | VitalScreen is an in vitro diagnostic kit for the semi-quantitative determination of human sperm |
Trademark Results [VitalScreen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VITALSCREEN 76426459 not registered Dead/Abandoned |
Planar Systems, Inc. 2002-07-01 |
 VITALSCREEN 76115649 2637623 Dead/Cancelled |
NDS SURGICAL IMAGING, LLC 2000-08-23 |
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