Barbiturates Intercept 5 Plate Kit

FDA UDI

Class II (US FDA UDI)

by OraSure Technologies, Inc.

Identity

Trade Name: Barbiturates Intercept 5 Plate Kit FDA UDI
Generic Name: Barbiturate IVD, kit, enzyme immunoassay (EIA) FDA UDI
Model / Reference: 1108IB FDA UDI

Identifiers

Primary DI / UDI-DI: 00608337000207 FDA UDI
510(k) Number: K001976 FDA UDI
FDA Product Code: DIS FDA UDI
GMDN Term: Barbiturate IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.3150 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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: Barbiturate IVD, kit, enzyme immunoassay (EIA)

Barbiturates Intercept 5 Plate Kit by OraSure Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K001976 also covers:

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: OraSure Technologies, Inc.

Sources (1)

FDA UDI 10bba94c-828b-4cdd-bb06-9027a37a7d94 35 fields · synced Jun 9, 2026