POINTE SCIENTIFIC Bilirubin, Total

FDA UDI

Class II (US FDA UDI)

by Pointe Scientific, Inc.

Identity

Trade Name: POINTE SCIENTIFIC Bilirubin, Total FDA UDI
Generic Name: Total bilirubin IVD, kit, spectrophotometry FDA UDI
Device Name: For the quantitative determination of direct bilirubin in serum. FDA UDI
Model / Reference: B7576-1L FDA UDI
Description: For the quantitative determination of direct bilirubin in serum. FDA UDI

Identifiers

Catalog Number: B7576-1L FDA UDI
Primary DI / UDI-DI: 00811727010452 FDA UDI
510(k) Number: K832870 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Total bilirubin IVD, kit, spectrophotometry

POINTE SCIENTIFIC Bilirubin, Total 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

K832870 also covers:

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 bda93bc3-55dd-4a3b-aedc-e0d591b460a1 37 fields · synced May 30, 2026