Pediatric Bilirubin Control Level 2 Set 3x3mL

FDA UDI

Class I (US FDA UDI)

by Quantimetrix Corp.

Identity

Trade Name: Pediatric Bilirubin Control Level 2 Set 3x3mL FDA UDI
Generic Name: Total bilirubin IVD, control FDA UDI
Device Name: The Pediatric Bilirubin Control is intended as a means of monitoring various bilirubin assay methods to validate quantitation of patient samples. It is supplied as a liquid, 3x3mL vials per box. It is prepared from purified bilirubin in a human protein base, stabilizers and preservatives have been added. FDA UDI
Model / Reference: 1332-31 FDA UDI
Description: The Pediatric Bilirubin Control is intended as a means of monitoring various bilirubin assay methods to validate quantitation of patient samples. It is supplied as a liquid, 3x3mL vials per box. It is prepared from purified bilirubin in a human protein base, stabilizers and preservatives have been added. FDA UDI

Identifiers

Catalog Number: 1332-31 FDA UDI
Primary DI / UDI-DI: 00896863002301 FDA UDI
510(k) Number: K860942 FDA UDI
FDA Product Code: JJY FDA UDI
GMDN Term: Total bilirubin IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 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

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

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Manufacturing Date

FDA UDI

Category: Total bilirubin IVD, control

Pediatric Bilirubin Control Level 2 Set 3x3mL by Quantimetrix Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Total bilirubin IVD, control.

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Cleared under the same submission

K860942 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 I	Pending data

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Manufacturer

Manufacturer: Quantimetrix Corp.

Sources (1)

FDA UDI 5223cfc0-2be6-4243-8416-39176e31999d 37 fields · synced May 31, 2026