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Incup

FDA UDI

Class II (US FDA UDI)

by American Bio Medica Corp.

Identity

Trade Name
INCUP FDA UDI
Generic Name
Multiple therapeutic drugs/drugs of abuse IVD, calibrator FDA UDI
Device Name
InCup with THC/OPI300/METH/BZO/MDMA/COC/BAR FDA UDI
Model / Reference
10-7SPC-283 FDA UDI
Description
InCup with THC/OPI300/METH/BZO/MDMA/COC/BAR FDA UDI

Identifiers

Catalog Number
10-7SPC-283 FDA UDI
Primary DI / UDI-DI
10694644400721 FDA UDI
510(k) Number
K073078 FDA UDI
FDA Product Code
LAG FDA UDI
GMDN Term
Multiple therapeutic drugs/drugs of abuse IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3610 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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
MRI Safety
MR Safe FDA UDI

Category: Multiple therapeutic drugs/drugs of abuse IVD, calibrator

Incup by American Bio Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple therapeutic drugs/drugs of abuse IVD, calibrator.

Cleared under the same submission

K073078 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American Bio Medica Corp.

Sources (1)

  • FDA UDI 37a4027f-f757-49bf-8641-611fd6a5f946 36 fields · synced May 30, 2026