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Rapid TOX

FDA UDI

Class U (US FDA UDI)

by American Bio Medica Corp.

Identity

Trade Name
Rapid TOX FDA UDI
Generic Name
Multiple therapeutic drugs/drugs of abuse IVD, calibrator FDA UDI
Device Name
8 Rapid Tox w/BUP FDA UDI
Model / Reference
10-8BT-530 FDA UDI
Description
8 Rapid Tox w/BUP FDA UDI

Identifiers

Catalog Number
10-8BT-530 FDA UDI
Primary DI / UDI-DI
10694644100201 FDA UDI
FDA Product Code
LCM FDA UDI
LFG FDA UDI
LDJ FDA UDI
JXN FDA UDI
DJG FDA UDI
DJR FDA UDI
DJC FDA UDI
DIO FDA UDI
JXM FDA UDI
DIS FDA UDI
DKG FDA UDI
GMDN Term
Multiple therapeutic drugs/drugs of abuse IVD, calibrator FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
862.3910 FDA UDI
862.3870 FDA UDI
862.3700 FDA UDI
862.3650 FDA UDI
862.3620 FDA UDI
862.3610 FDA UDI
862.3250 FDA UDI
862.3170 FDA UDI
862.3150 FDA UDI
862.2270 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

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

Rapid TOX by American Bio Medica Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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 aad8a842-2f9a-477e-83a5-7cc8aa7a82ec 36 fields · synced May 30, 2026