FDA UDI
In Commercial Distribution
🇺🇸 United States
SpermMar IgA Latex Particles
DI: 00805360018388
·
Model: 15511
·
VITROLIFE INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SpermMar IgA Latex Particles
- Primary DI
- 00805360018388
- Version / Model
- 15511
- Company Name
- VITROLIFE INC.
- Labeler DUNS
- 051915038
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-23
- Public Version
- 2
- Public Version Date
- 2020-04-29
- Public Version Status
- Update
- Public Device Record Key
- 7f83dbb6-c802-43b0-a5cc-4eeba3592b9c
Device Description
SpermMar IgA Latex Particles
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 |
|---|---|---|---|---|
| DFQ | Sperm, Antigen, Antiserum, Control | Immunology | 866.5800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55181 | Sperm antibody IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of anti-sperm antibodies in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00805360018388 | GS1 |