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Liquichek

FDA UDI

Class I (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
Liquichek FDA UDI
Generic Name
Multiple infectious organism/newborn TORCH screen IVD, control FDA UDI
Device Name
Liquichek ToRCH Plus IgM Control, Positive MiniPak (A human serology IgM Control.) FDA UDI
Model / Reference
229PX FDA UDI
Description
Liquichek ToRCH Plus IgM Control, Positive MiniPak (A human serology IgM Control.) FDA UDI

Identifiers

Catalog Number
229PX FDA UDI
Primary DI / UDI-DI
00847661000501 FDA UDI
510(k) Number
K040822 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
Multiple infectious organism/newborn TORCH screen 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

No

FDA UDI

Single Use

Yes

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: Multiple infectious organism/newborn TORCH screen IVD, control

Liquichek by Bio-Rad Laboratories — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple infectious organism/newborn TORCH screen IVD, control.

Cleared under the same submission

K040822 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA UDI be75a956-6325-4f36-a13b-424ff3a40ae8 37 fields · synced May 30, 2026