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m2000

FDA UDI

Class II (US FDA UDI)

by Abbott Molecular

Identity

Trade Name
m2000 FDA UDI
Generic Name
Microplate IVD FDA UDI
Device Name
96-Well Optical Reaction Plate FDA UDI
Model / Reference
4J71-70 FDA UDI
Description
96-Well Optical Reaction Plate FDA UDI

Identifiers

Catalog Number
4J71-70 FDA UDI
Primary DI / UDI-DI
00884999006522 FDA UDI
510(k) Number
K092705 FDA UDI
FDA Product Code
OOI FDA UDI
JJH FDA UDI
GMDN Term
Microplate IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.2570 FDA UDI
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 II — 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 6e0bdbf3-8af4-4ee4-9e4a-1d0feebe4061 36 fields · synced Jun 8, 2026