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RTCII 2nd gen.

FDA UDI

Class U (US FDA UDI)

by American Bio Medica Corp.

Identity

Trade Name
RTCII 2nd gen. FDA UDI
Generic Name
Multiple therapeutic drugs/drugs of abuse IVD, calibrator FDA UDI
Device Name
12 DRUG MINICUP WITH THE ADDIT FDA UDI
Model / Reference
10-14PTX3-030 FDA UDI
Description
12 DRUG MINICUP WITH THE ADDIT FDA UDI

Identifiers

Catalog Number
10-14PTX3-030 FDA UDI
Primary DI / UDI-DI
10694644500070 FDA UDI
510(k) Number
K073078 FDA UDI
FDA Product Code
LCM FDA UDI
DKZ FDA UDI
JXM FDA UDI
DJR FDA UDI
LFI FDA UDI
JXN FDA UDI
LAG FDA UDI
DJG FDA UDI
DIO FDA UDI
DKE FDA UDI
GMDN Term
Multiple therapeutic drugs/drugs of abuse IVD, calibrator FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
862.3100 FDA UDI
862.3170 FDA UDI
862.3620 FDA UDI
862.3910 FDA UDI
862.3700 FDA UDI
862.3610 FDA UDI
862.3650 FDA UDI
862.3250 FDA UDI
862.3870 FDA UDI
Commercial Distribution
Not 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

RTCII 2nd gen. by American Bio Medica Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 0594d13a-8278-45fa-9e05-84015dc4bc34 38 fields · synced Jun 1, 2026