FDA UDI
In Commercial Distribution
🇺🇸 United States
Pointe G6PD Controls
DI: 00811727015679
·
Model: G7583-CTL
·
POINTE SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pointe G6PD Controls
- Primary DI
- 00811727015679
- Version / Model
- G7583-CTL
- Catalog Number
- G7583-CTL
- Company Name
- POINTE SCIENTIFIC, INC.
- Labeler DUNS
- 045623154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-30
- Public Version
- 1
- Public Version Date
- 2021-02-08
- Public Version Status
- New
- Public Device Record Key
- b11a915d-7989-43a0-8790-bab280671f1d
Device Description
Pointe G6PD Controls, 2x0.5ml L1, 2x0.5ml L2, Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood. For in vitro diagnostic use only.
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 |
|---|---|---|---|---|
| JBF | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening | Hematology | 864.7360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55936 | Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) enzyme activity of red cells from a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811727015679 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K024006 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius