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Lyphochek

FDA UDI

Class I (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
Lyphochek FDA UDI
Generic Name
Multiple biogenic amine neurotransmitter IVD, control FDA UDI
Device Name
Lyphochek Endocrine Control Bilevel (A human serum quantitative catecholamines control.) FDA UDI
Model / Reference
535 FDA UDI
Description
Lyphochek Endocrine Control Bilevel (A human serum quantitative catecholamines control.) FDA UDI

Identifiers

Catalog Number
535 FDA UDI
Primary DI / UDI-DI
00847661000976 FDA UDI
510(k) Number
K933317 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
Multiple biogenic amine neurotransmitter 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 biogenic amine neurotransmitter IVD, control

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

Similar devices

Also classified as Multiple biogenic amine neurotransmitter IVD, control.

Cleared under the same submission

K933317 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 bbe9c359-0f1f-4fa0-834a-8420da5566b5 37 fields · synced May 30, 2026