FDA UDI
In Commercial Distribution
🇺🇸 United States
Phosphate (Inorganic) ver.2
DI: 07613336121481
·
Model: 08058610190
·
Roche Diagnostics GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Phosphate (Inorganic) ver.2
- Primary DI
- 07613336121481
- Version / Model
- 08058610190
- Catalog Number
- 08058610190
- Company Name
- Roche Diagnostics GmbH
- Labeler DUNS
- 315028860
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-05
- Public Version
- 3
- Public Version Date
- 2026-02-23
- Public Version Status
- Update
- Public Device Record Key
- aeb622ad-70bb-44b7-856d-db50bdd43e3c
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| CEO | Phosphomolybdate (colorimetric), inorganic phosphorus | Clinical Chemistry | 862.1580 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59123 | Inorganic phosphate (PO43-) IVD, kit, spectrophotometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of inorganic phosphate (PO43-) [phosphorus] in a clinical specimen using a spectrophotometry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613336121481 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K983503 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius