FDA UDI
In Commercial Distribution
🇺🇸 United States
SpermMar Test IgG - single kit
DI: 05411967000036
·
Model: SPMG_S
·
Fertipro NV
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SpermMar Test IgG - single kit
- Primary DI
- 05411967000036
- Version / Model
- SPMG_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
- 40b31b05-ad95-47b9-9a08-6a1a0cc71c8b
Device Description
SpermMar Test IgG is a qualitative Latex Test for detection of Sperm Antibodies. The SpermMar Test IgG is a diagnostic kit for detecting antisperm antibodies of the IgG class in human semen or serum. The direct SpermMar Test IgG can be performed on untreated human semen provided it contains motile spermatozoa, the indirect SpermMar Test IgG can be used on serum. 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 | 05411967000036 | GS1 |
Customer Contacts
- Phone
- +3250791805
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius