FDA UDI
In Commercial Distribution
🇺🇸 United States
MP Biomedicals LLC
DI: 00817830023013
·
Model: 07109202
·
Mp Biomedicals, LLC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MP Biomedicals LLC
- Primary DI
- 00817830023013
- Version / Model
- 07109202
- Catalog Number
- 07109202
- Company Name
- Mp Biomedicals, LLC
- Labeler DUNS
- 614875644
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-01
- Public Version
- 1
- Public Version Date
- 2023-08-09
- Public Version Status
- New
- Public Device Record Key
- 508beafa-7e99-4117-b419-b05115d22276
Device Description
IMMUCHEM DOUBLE ANTIBODY ANDROSTENEDIONE 125I RIA 100 TUBE KIT
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58400 | Androstenedione IVD, kit, radioimmunoassay | A collection of reagents and other associated materials intended to be used for the quantitative measurement of androstenedione in a clinical specimen, using a radioimmunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817830023013 | GS1 |