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Bilirubin Mid-Range Standard

FDA UDI

Class II (US FDA UDI)

by Verichem Laboratories, Inc.

Identity

Trade Name
Bilirubin Mid-Range Standard FDA UDI
Generic Name
Conjugated (direct) bilirubin IVD, calibrator FDA UDI
Device Name
Calibrator / Calibration Verifier FDA UDI
Model / Reference
9575 FDA UDI
Description
Calibrator / Calibration Verifier FDA UDI

Identifiers

Primary DI / UDI-DI
00852553007322 FDA UDI
510(k) Number
K882059 FDA UDI
FDA Product Code
JIT FDA UDI
GMDN Term
Conjugated (direct) bilirubin IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 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

No

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, calibrator

Bilirubin Mid-Range Standard by Verichem Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Conjugated (direct) bilirubin IVD, calibrator.

Cleared under the same submission

K882059 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Verichem Laboratories, Inc.

Sources (1)

  • FDA UDI 77f3d97f-543b-4c38-95b0-c13eda0552e8 35 fields · synced May 30, 2026