Intercept i2 Oral Fluid Collection Device

FDA UDIEUDAMED

Class I (US FDA UDI)

by OraSure Technologies, Inc.

Identity

Trade Name: Intercept i2 Oral Fluid Collection Device FDA UDI
Generic Name: Absorbent tipped applicator, non-sterile FDA UDI
Model / Reference: 3001-2661 FDA UDI

Identifiers

Primary DI / UDI-DI: 00608337000917 FDA UDI
FDA Product Code: NNK FDA UDI
GMDN Term: Absorbent tipped applicator, non-sterile FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.3250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Absorbent tipped applicator, non-sterile

Intercept i2 Oral Fluid Collection Device by OraSure Technologies, Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: OraSure Technologies, Inc.

Sources (2)

FDA UDI 98c43815-564d-48d3-bb40-d1ef4408baeb 34 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 2, 2026