FDA UDI
In Commercial Distribution
🇺🇸 United States
Pointe Direct Bilirubin for BS480
DI: 00811727015822
·
Model: 14-HB936-200
·
POINTE SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pointe Direct Bilirubin for BS480
- Primary DI
- 00811727015822
- Version / Model
- 14-HB936-200
- Catalog Number
- 14-HB936-200
- Company Name
- POINTE SCIENTIFIC, INC.
- Labeler DUNS
- 045623154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-28
- Public Version
- 1
- Public Version Date
- 2020-06-05
- Public Version Status
- New
- Public Device Record Key
- 813dc434-9e36-45a8-adf0-553ced8aa45d
Device Description
Pointe Direct Bilirubin Reagent packaged for the BS480 analyzer. 4x40mL, 4x10mL Kit. For the quantitative determination of direct bilirubin in serum on the BS480 analyzers. 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 |
|---|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | Clinical Chemistry | 862.1110 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53236 | Conjugated (direct) bilirubin 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 conjugated (direct) bilirubin in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811727015822 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040391 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius