FDA UDI
In Commercial Distribution
🇺🇸 United States
SpermMar Test IgA - single kit
DI: 05411967002566
·
Model: SPMA_S
·
Fertipro NV
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SpermMar Test IgA - single kit
- Primary DI
- 05411967002566
- Version / Model
- SPMA_S
- 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
- 2019-12-11
- Public Version Status
- Update
- Public Device Record Key
- 1a3ed3cf-04e2-4658-8b50-fc92a554b8a1
Device Description
SpermMar Test IgA is a qualitative beads test for detection of sperm antibodies of the IgA class. The Spermar Test IgA is a diagnostic kit for detecting antisperm antibodies of the IgA class in human semen. The presence of antisperm antibodies can interfere with sperm function and zona binding and the acrosome reaction. More information can be found at 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 |
|---|---|---|---|---|
| KTO | Reagent, Immunoassay, Igg | Immunology | 866.5530 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55180 | Sperm antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of anti-sperm antibodies in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05411967002566 | GS1 | ||||
| Package | 05411967000029 | GS1 | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +3250791805
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 0.7 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius