Fertility Solutions FSI103
GUDID 08600105181066
Sperm Count Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 levels - high and low concentrations. https://www.fertilitysolutions.com/product-category/sperm-count-quality-control
Fertility Solutions, Inc.
Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control Sperm concentration indicator IVD, control| Primary Device ID | 08600105181066 |
| NIH Device Record Key | 00920ff0-dbc5-41fb-9ccc-99ac70e50877 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fertility Solutions |
| Version Model Number | FSI103 |
| Catalog Number | FSI103 |
| Company DUNS | 794781583 |
| Company Name | Fertility Solutions, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08600105181066 [Primary] |
FDA Product Code
| NRF | Material, Quality Control, Semen Analysis |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-25 |
| Device Publish Date | 2023-09-15 |
On-Brand Devices [Fertility Solutions]
| 86001051819986 | Spermocytometer® sperm counting chambers. Box of 25 disposable slides each containing 2 single |
| 08600105181370 | Post Vasectomy Quality Control containing stabilized human sperm, 2 vials of 150 µL each, 2 le |
| 08600105181202 | Post Vasectomy Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 le |
| 08600105181134 | Sperm Count Quality Control containing stabilized human sperm, 2 vials of 150 µL each, 2 level |
| 08600105181066 | Sperm Count Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 level |
| 00860010518137 | Post Vasectomy Quality Control containing stabilized human sperm, 2 vials of 150 µL each, 2 le |
| 00860010518120 | Post Vasectomy Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 le |
| 00860010518113 | Sperm Count Quality Control containing stabilized human sperm, 2 vials of 150 µL each, 2 level |
| 00860010518106 | Sperm Count Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 level |
Trademark Results [Fertility Solutions]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FERTILITY SOLUTIONS 85463145 4315593 Live/Registered |
Fertility Solutions, Inc. 2011-11-03 |
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