FDA UDI
In Commercial Distribution
🇺🇸 United States
Pointe Scientific, Inc. Magnesium
DI: 00811727014795
·
Model: HM929-120
·
HORIBA INSTRUMENTS INCORPORATED
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Pointe Scientific, Inc. Magnesium
- Primary DI
- 00811727014795
- Version / Model
- HM929-120
- Catalog Number
- HM929-120
- Company Name
- HORIBA INSTRUMENTS INCORPORATED
- Labeler DUNS
- 052845583
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 4
- Public Version Date
- 2025-10-02
- Public Version Status
- Update
- Public Device Record Key
- 4e0db72e-fe15-498a-bc63-6c112562be1e
Device Description
Pointe Magnesium Reagent is for the quantitative determination of magnesium in serum. For in vitro diagnostic use only. 2 x 30ml, 2 x 30ml
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 52883 | Magnesium (Mg2+) 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 quantitative measurement of magnesium (Mg2+) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811727014795 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K853592 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius