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m2000

FDA UDI

Class I (US FDA UDI)

by Abbott Molecular

Identity

Trade Name
m2000 FDA UDI
Generic Name
Microplate IVD FDA UDI
Device Name
96 Deep-Well Plates FDA UDI
Model / Reference
04J71-30 FDA UDI
Description
96 Deep-Well Plates FDA UDI

Identifiers

Catalog Number
04J71-30 FDA UDI
Primary DI / UDI-DI
00884999006485 FDA UDI
510(k) Number
K092705 FDA UDI
FDA Product Code
JJH FDA UDI
GMDN Term
Microplate IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2310 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

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Microplate IVD

m2000 by Abbott Molecular — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microplate IVD.

Cleared under the same submission

K092705 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Molecular

Sources (1)

  • FDA UDI 63906ab7-08bc-4d57-85fa-7e82aef65a5c 36 fields · synced Jun 8, 2026