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Rds

FDA UDI

Class II (US FDA UDI)

by American Bio Medica Corp.

Identity

Trade Name
RDS FDA UDI
Generic Name
Multiple therapeutic drugs/drugs of abuse IVD, calibrator FDA UDI
Device Name
2 Panel w/THC&CocSingle 25/BOX FDA UDI
Model / Reference
10-2C1-000 FDA UDI
Description
2 Panel w/THC&CocSingle 25/BOX FDA UDI

Identifiers

Catalog Number
10-2C1-000 FDA UDI
Primary DI / UDI-DI
10694644300076 FDA UDI
510(k) Number
K002447 FDA UDI
FDA Product Code
LFI FDA UDI
LDJ FDA UDI
LCM FDA UDI
JXM FDA UDI
DJG FDA UDI
DJC FDA UDI
DIS FDA UDI
DIO FDA UDI
DZK FDA UDI
GMDN Term
Multiple therapeutic drugs/drugs of abuse IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3910 FDA UDI
862.3870 FDA UDI
862.3170 FDA UDI
862.3650 FDA UDI
862.3610 FDA UDI
862.3150 FDA UDI
862.3250 FDA UDI
872.4880 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

Rds 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

K002447 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 a8b09eec-7ac8-4921-8149-84837c4c5182 37 fields · synced Jun 8, 2026