FDA UDI
In Commercial Distribution
🇺🇸 United States
TOTAL BILIRUBIN-SL Assay
DI: 00628063400188
·
Model: 243-10
·
SEKISUI DIAGNOSTICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TOTAL BILIRUBIN-SL Assay
- Primary DI
- 00628063400188
- Version / Model
- 243-10
- Catalog Number
- 243-10
- Company Name
- SEKISUI DIAGNOSTICS, LLC
- Labeler DUNS
- 966812344
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 4
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7b3fa359-8e43-41f6-b30d-8bc3667dff62
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 |
|---|---|---|---|---|
| 53229 | Total bilirubin IVD, kit, spectrophotometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total bilirubin in a clinical specimen, using a spectrophotometry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628063400188 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K974874 | 000 |