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BioCode MDx 3000

FDA UDI

Class II (US FDA UDI)

by Applied BioCode, Inc.

Identity

Trade Name
BioCode MDx 3000 FDA UDI
Generic Name
Microplate reader IVD, automated/semi-automated FDA UDI
Device Name
The BioCode MDx 3000 is an automated molecular diagnostic system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) assays. FDA UDI
Model / Reference
1 FDA UDI
Description
The BioCode MDx 3000 is an automated molecular diagnostic system for use with Applied BioCode’s Barcoded Magnetic Beads (BMB) assays. FDA UDI

Identifiers

Catalog Number
41-A0051 FDA UDI
Primary DI / UDI-DI
00851034007004 FDA UDI
510(k) Number
K180041 FDA UDI
FDA Product Code
OOI FDA UDI
PCH FDA UDI
GMDN Term
Microplate reader IVD, automated/semi-automated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.2570 FDA UDI
866.3990 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Microplate reader IVD, automated/semi-automated

BioCode MDx 3000 by Applied BioCode, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microplate reader IVD, automated/semi-automated.

Cleared under the same submission

K180041 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Applied BioCode, Inc.

Sources (1)

  • FDA UDI 85a52091-6381-461b-a61c-ae3f412836bb 37 fields · synced May 31, 2026