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Direct Bilirubin Reagent Set

FDA UDI

Class II (US FDA UDI)

by Clinical Diagnostic Solutions, Inc.

Identity

Trade Name
Direct Bilirubin Reagent Set FDA UDI
Generic Name
Conjugated (direct) bilirubin IVD, kit, enzyme spectrophotometry FDA UDI
Device Name
For the quantitative determination of direct bilirubin in serum. FDA UDI
Model / Reference
R1 x 500mL, R2 x 15mL FDA UDI
Description
For the quantitative determination of direct bilirubin in serum. FDA UDI

Identifiers

Catalog Number
501-402 FDA UDI
Primary DI / UDI-DI
00812137011893 FDA UDI
FDA Product Code
CIG FDA UDI
GMDN Term
Conjugated (direct) bilirubin IVD, kit, enzyme 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

No

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, kit, enzyme spectrophotometry

Direct Bilirubin Reagent Set by Clinical Diagnostic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Conjugated (direct) bilirubin IVD, kit, enzyme spectrophotometry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clinical Diagnostic Solutions, Inc.

Sources (1)

  • FDA UDI 9b9a699c-ba91-45fb-9872-024e4c8ed2fc 36 fields · synced Jun 8, 2026