FDA UDI
In Commercial Distribution
🇺🇸 United States
AQC
DI: 00860010518182
·
Model: AQC305
·
Fertility Solutions, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AQC
- Primary DI
- 00860010518182
- Version / Model
- AQC305
- Catalog Number
- AQC305
- Company Name
- Fertility Solutions, Inc.
- Labeler DUNS
- 794781583
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-15
- Public Version
- 1
- Public Version Date
- 2024-04-23
- Public Version Status
- New
- Public Device Record Key
- a5cba994-831a-490a-a2b1-122918aaf7ca
Device Description
Sperm Morphology Virtumorph® Quality Control - 1 fifty cell Virtumorph® printed virtual semen morphology smear and 1 Pap stained and coverslipped glass sperm morphology smear, 2 levels - a high and a low value. https://www.fertilitysolutions.com/product-category/sperm-morphology-quality-control
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LJG | Quality Control Slides | Microbiology | 866.2660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67049 | Sperm morphology/viability control IVD | A prepared slide with a fixed semen smear, or a high-resolution colour printed image of stained or unstained normal sperm, intended to be used as reference material in the analysis of a semen specimen, to determine sperm morphology and/or viability. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860010518182 | GS1 |
Customer Contacts
- Phone
- 216-491-0030
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a dark, dry place at 20-25 C