Identity
- Trade Name
- Pointe Direct Bilirubin for BS480 FDA UDI
- Generic Name
- Conjugated (direct) bilirubin IVD, reagent FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 14-HB936-200 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 14-HB936-200 FDA UDI
- Primary DI / UDI-DI
- 00811727015822 FDA UDI
- 510(k) Number
- K040391 FDA UDI
- FDA Product Code
- CIG FDA UDI
- GMDN Term
- Conjugated (direct) bilirubin IVD, reagent 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: Conjugated (direct) bilirubin IVD, reagent
Pointe Direct Bilirubin for BS480 by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Conjugated (direct) bilirubin IVD, reagent.
- Alinity — Abbott · Class II
- D BIL — Randox Laboratories, Ltd. · Class II
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II
- ClearChem Diagnostics Inc. Direct Bilirubin — CLEARCHEM DIAGNOSTICS INC. · Class II
- ARCHITECT — Abbott · Class II
- Teco Diagnostics Direct Bilirubin TC-Matrix — TECO DIAGNOSTICS · Class II
- IDG/Sanzay — IDG/SANZAY Corporation · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
Cleared under the same submission
K040391 also covers:
- Direct Bilirubin — POINTE SCIENTIFIC, INC.
- Pointe Direct Bilirubin Reagent — 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.
- 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 |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 813dc434-9e36-45a8-adf0-553ced8aa45d 37 fields · synced May 30, 2026