FDA UDI
In Commercial Distribution
🇺🇸 United States
Pointe Scientific, Inc. Total Protein
DI: 00811727012005
·
Model: T7528-1L
·
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. Total Protein
- Primary DI
- 00811727012005
- Version / Model
- T7528-1L
- Catalog Number
- T7528-1L
- 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
- 0bb20503-c208-498b-a376-3824122368e7
Device Description
Pointe Scientific, Inc. Total Protein Reagent for the quantitative determination of total protein concentration in serum. 1 x 1 liter.
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 |
|---|---|---|---|---|
| 53989 | Total protein 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 total protein in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811727012005 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K822468 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius