Identity
- Trade Name
- Pointe Total Bilirubin Reagent FDA UDI
- Generic Name
- Total bilirubin IVD, kit, spectrophotometry FDA UDI
- Device Name
- Pointe Total Bilirubin Reagent packaged for use on the Mindray BS480. 5 x 58ml R1, 5 x 15ml R2. For the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. FDA UDI
- Model / Reference
- 14-HB979-365 FDA UDI
- Description
- Pointe Total Bilirubin Reagent packaged for use on the Mindray BS480. 5 x 58ml R1, 5 x 15ml R2. For the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. FDA UDI
Identifiers
- Catalog Number
- 14-HB979-365 FDA UDI
- Primary DI / UDI-DI
- 00811727015952 FDA UDI
- 510(k) Number
- K040391 FDA UDI
- FDA Product Code
- CIG FDA UDI
- GMDN Term
- Total bilirubin IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1110 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total bilirubin IVD, kit, spectrophotometry
Pointe Total Bilirubin Reagent by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total bilirubin IVD, kit, spectrophotometry.
- CAROLINA LIQUID CHEMISTRIES CORP.® TBIL RGT. KIT BL-228 — Carolina Liquid Chemistries Corp. · Class II
- ADVIA® Chemistry Total Bilirubin_2 TBIL_2 Reagents — Siemens Healthcare Diagnostics · Class I
- Total Bilirubin LiquiColor® — STANBIO LABORATORY, L.P. · Class II
- Bilirubin Total Gen.3 — Roche Diagnostics Corp. · Class II
- TOTAL BILIRUBIN-SL-X — Sekisui Diagnostics, LLC · Class II
- Alinity — ABBOTT IRELAND · Class I
- Direct Bilirubin — Roche Diagnostics Corp. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.™ TBIL TOTAL BILIRUBIN REAGENT CC228 — Carolina Liquid Chemistries Corp. · Class II
Cleared under the same submission
K040391 also covers:
- Direct Bilirubin — POINTE SCIENTIFIC, INC.
- Pointe Direct Bilirubin Reagent — POINTE SCIENTIFIC, INC.
- Pointe Direct Bilirubin for BS480 — POINTE SCIENTIFIC, INC.
- Pointe Scientfic, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific — POINTE SCIENTIFIC, INC.
- Pointe Scientific — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Bilirubin, Direct — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Bilirubin, Total — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Direct Bilirubin — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. Total Bilirubin — POINTE SCIENTIFIC, INC.
- Pointe Total Bilirubin Reagent — POINTE SCIENTIFIC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 9251324b-53a5-4874-88d0-6d15373dab38 37 fields · synced May 30, 2026