FDA UDI
In Commercial Distribution
🇺🇸 United States
Spermac Stain - Stain C (250ml)
DI: 05411967001606
·
Model: SPS250C
·
Fertipro NV
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Spermac Stain - Stain C (250ml)
- Primary DI
- 05411967001606
- Version / Model
- SPS250C
- 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
- 2
- Public Version Date
- 2019-12-10
- Public Version Status
- Update
- Public Device Record Key
- 8665a2a1-1cee-41d9-84e4-cd0b979d0ed8
Device Description
Spermac Stain is a qualitative diagnostic kit for staining human spermatozoa. The purpose of staining spermatozoa is to be able to differentiate morphologically normal from abnormal sperm cells. 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 |
|---|---|---|---|---|
| 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 | 05411967001606 | GS1 |
Customer Contacts
- Phone
- +3250791805
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 250 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius