Rapid TOX

FDA UDI

Class U (US FDA UDI)

by American Bio Medica Corp.

Identity

Trade Name: Rapid TOX FDA UDI
Generic Name: Barbiturate IVD, calibrator FDA UDI
Device Name: RapidTOX Barb single 50/case FDA UDI
Model / Reference: 10-BART-000 FDA UDI
Description: RapidTOX Barb single 50/case FDA UDI

Identifiers

Catalog Number: 10-BART-000 FDA UDI
Primary DI / UDI-DI: 10694644100263 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: Barbiturate 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

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Barbiturate 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 Barbiturate IVD, calibrator.

Barbiturate DAU Calibrator, Calibrator #5 — Lin-Zhi International, Inc. · Class II
Pointe Barbiturate Calibrator/Control (Secobarbital 200 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
Pointe Barbiturate Calibrator/Control (Secobarbital 100 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
Barbiturate DAU Calibrator/Control, Calibrator #4/Cutoff B/Control 3 — Lin-Zhi International, Inc. · Class I
Pointe Barbiturate Calibrator/Control (Secobarbital 300 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
Barbiturate DAU Calibrator/Control, Calibrator #2/Control 1 — Lin-Zhi International, Inc. · Class I
Pointe Barbiturate Calibrator (Secobarbital 1000 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
Barbiturate DAU Calibrator/Control, Calibrator #3/Cutoff A/Control 2 — Lin-Zhi International, Inc. · Class I

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 U	Pending data

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Manufacturer

Manufacturer: American Bio Medica Corp.

Sources (1)

FDA UDI b081d903-b982-447f-afce-a52e9cc4556d 36 fields · synced Jun 1, 2026