← Back to catalogue

Remel

FDA UDI

Class I (US FDA UDI)

by Remel, Inc.

Identity

Trade Name
REMEL FDA UDI
Generic Name
Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI
Device Name
Fuji Medium (10ml) 20/PK FDA UDI
Model / Reference
R07676 FDA UDI
Description
Fuji Medium (10ml) 20/PK FDA UDI

Identifiers

Catalog Number
R07676 FDA UDI
Primary DI / UDI-DI
00848838011535 FDA UDI
FDA Product Code
JWZ FDA UDI
GMDN Term
Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent

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

Similar devices

Also classified as Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent.

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 3a47bd77-bc46-4bca-95d8-97f756cf9b5e 34 fields · synced May 30, 2026