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MicroTest M4RT

FDA UDI

Class I (US FDA UDI)

by Remel, Inc.

Identity

Trade Name
MicroTest M4RT FDA UDI
Generic Name
Microbiological transport medium IVD FDA UDI
Device Name
M4RT(3ml) Universal Flock Swab Kit PK/100 FDA UDI
Model / Reference
R12567 FDA UDI
Description
M4RT(3ml) Universal Flock Swab Kit PK/100 FDA UDI

Identifiers

Catalog Number
R12567 FDA UDI
Primary DI / UDI-DI
00848838074844 FDA UDI
510(k) Number
K965152 FDA UDI
FDA Product Code
JSM FDA UDI
GMDN Term
Microbiological transport medium IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2390 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Microbiological transport medium IVD

MicroTest M4RT by Remel, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Microbiological transport medium IVD.

Cleared under the same submission

K965152 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Remel, Inc.

Sources (1)

  • FDA UDI c7139182-bffe-49ad-817e-c3586beea5fe 35 fields · synced Jun 8, 2026