FDA UDI
In Commercial Distribution
🇺🇸 United States
Ionify Steroids 2
DI: 07613336232132
·
Model: 09634444160
·
Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Ionify Steroids 2
- Primary DI
- 07613336232132
- Version / Model
- 09634444160
- Catalog Number
- 09634444160
- Company Name
- Roche Diagnostics GmbH
- Labeler DUNS
- 315028860
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-11
- Public Version
- 1
- Public Version Date
- 2025-12-19
- Public Version Status
- New
- Public Device Record Key
- 20e4d626-1bec-401d-a2ab-b903d96fd20d
Device Description
Ionify DHEA Ionify DHEA-S Ionify 17-Hydroxyprogesterone Ionify Progesterone
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| JKC | RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE) | Clinical Chemistry | 862.1245 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59017 | Multiple steroid hormone IVD, kit, mass spectrometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple steroid hormones in a clinical specimen, using a mass spectrometry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613336232132 | GS1 |