Spectra

FDA UDI

Class II (US FDA UDI)

by Remel, Inc.

Identity

Trade Name: SPECTRA FDA UDI
Generic Name: Differential/selective agar culture medium IVD FDA UDI
Device Name: SPECTRA ESBL 10/Pk FDA UDI
Model / Reference: R01810 FDA UDI
Description: SPECTRA ESBL 10/Pk FDA UDI

Identifiers

Catalog Number: R01810 FDA UDI
Primary DI / UDI-DI: 00848838085628 FDA UDI
510(k) Number: K162620 FDA UDI
FDA Product Code: JSO FDA UDI
GMDN Term: Differential/selective agar culture medium IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.1700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Differential/selective agar culture medium IVD

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

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Cleared under the same submission

K162620 also covers:

SPECTRA — REMEL, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Remel, Inc.

Sources (1)

FDA UDI c7252d93-870c-48d7-8fd3-7a47eee71192 35 fields · synced May 30, 2026