FDA UDI
In Commercial Distribution
🇺🇸 United States
Pointe Scientific, Inc. Microalbumin
DI: 00811727011886
·
Model: M7562-100
·
POINTE SCIENTIFIC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pointe Scientific, Inc. Microalbumin
- Primary DI
- 00811727011886
- Version / Model
- M7562-100
- Catalog Number
- M7562-100
- Company Name
- POINTE SCIENTIFIC, INC.
- Labeler DUNS
- 045623154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 0d34b507-9748-44b4-8c46-e71a67cc81d6
Device Description
Pointe Scientific, Inc. Microalbumin Reagent for the quantitative determination of low levels of albumin in urine by immunoturbidimetric assay. For in vitro diagnostic use. 4 x 20 ml., 2 x 10 ml.
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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JIT | Calibrator, Secondary | Clinical Chemistry | 862.1150 | 2 |
| DDZ | Albumin, Fitc, Antigen, Antiserum, Control | Immunology | 866.5040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53479 | Microalbumin 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 microalbumin in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811727011886 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K023860 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius