Identity
- Trade Name
- Pointe Scientific FDA UDI
- Generic Name
- Total bilirubin IVD, kit, spectrophotometry FDA UDI
- Device Name
- Total Bilirubin reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. 9 x 63ml, 9 x 16ml FDA UDI
- Model / Reference
- HB979-711 FDA UDI
- Description
- Total Bilirubin reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. 9 x 63ml, 9 x 16ml FDA UDI
Identifiers
- Catalog Number
- HB979-711 FDA UDI
- Primary DI / UDI-DI
- 00811727012944 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 Scientific by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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, 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 8806c205-0202-4eab-a1cd-9a88b0267264 37 fields · synced May 30, 2026