← Back to catalogue

Remel

FDA UDI

Class I (US FDA UDI)

by Remel, Inc.

Identity

Trade Name
REMEL FDA UDI
Generic Name
Microbiological transport medium IVD FDA UDI
Device Name
Regan Lowe Semi-Solid Transport 20/PK FDA UDI
Model / Reference
R064141 FDA UDI
Description
Regan Lowe Semi-Solid Transport 20/PK FDA UDI

Identifiers

Catalog Number
R064141 FDA UDI
Primary DI / UDI-DI
00848838009518 FDA UDI
510(k) Number
K834065 FDA UDI
FDA Product Code
JSN 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

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: Microbiological transport medium IVD

Remel 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

K834065 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Remel, Inc.

Sources (1)

  • FDA UDI b8cb519b-5ec7-485a-ab07-596b6b2ae8c7 35 fields · synced Jun 8, 2026