Is this your brand? Sign in to claim ownership.
Sign in to claim this brandAmerican Bio Medica Corp.
US
Last updated May 23, 2026
What American Bio Medica Corp. makes
American Bio Medica Corp. manufactures in-vitro diagnostics (IVDs) and calibrators for drug testing, including assays for buprenorphine, cocaine and its metabolites, methadone, amphetamines (both specific and group tests), and opiates with their metabolites. The company also produces rapid testing devices for influenza virus and respiratory syncytial virus (RSV) antigen detection.
The portfolio includes devices classified as Class I, Class II, and unclassified (U) under FDA regulations, with submissions recorded in the FDA 510(k) and Unique Device Identifier (UDI) databases. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does American Bio Medica Corp. manufacture?
American Bio Medica Corp. specializes in in-vitro diagnostics (IVDs) and calibrators primarily used for drug testing and viral antigen detection. Their portfolio includes assays for substances like buprenorphine, cocaine and its metabolites, methadone, amphetamines (both specific and group tests), and opiates with their metabolites. Additionally, they produce rapid testing devices for detecting influenza virus and respiratory syncytial virus (RSV) antigens. These devices are designed to assist in clinical, forensic, or treatment monitoring settings.
Where is American Bio Medica Corp. based?
American Bio Medica Corp. is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.
Which regulatory registries list American Bio Medica Corp.’s devices?
American Bio Medica Corp.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These registries track submissions for medical devices that have undergone the necessary regulatory pathways, such as premarket notifications (510(k)) or UDI assignments, to ensure compliance with U.S. regulatory requirements.
How are American Bio Medica Corp.’s devices classified under FDA regulations?
American Bio Medica Corp.’s devices are classified under three categories: Class I, Class II, and unclassified (U). The classification determines the regulatory controls applied to each device. For example, Class I devices generally pose the lowest risk and may require less stringent oversight, while Class II devices involve moderate risk and require special controls beyond general controls. Unclassified devices may require case-by-case evaluation based on their specific risks and intended use.
What is the purpose of the calibrators produced by American Bio Medica Corp.?
The calibrators produced by American Bio Medica Corp. are designed to ensure the accuracy and reliability of their in-vitro diagnostic tests. Calibrators provide reference standards that help laboratories or testing facilities validate the performance of their equipment and assays, ensuring consistent and precise results when detecting drugs of abuse, metabolites, or viral antigens. This is critical for maintaining the integrity of clinical or forensic testing.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (327)
Page 2 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| RTCII 2nd gen. | 10-9MOX3F-030 | FDA UDI | Class II | Unknown |
| Rapid TOX | 10-5BBT-000 | FDA UDI | Class I | Active |
| RTCII 1st gen. | 10-7MX2A-030 | FDA UDI | Class II | Active |
| Rds | 10-7SP-148 | FDA UDI | Class II | Active |
| RTCII 2nd gen. | 10-7MBZ3A-030 | FDA UDI | Class II | Unknown |
| Rapid TOX | 10-BZOT-000 | FDA UDI | Class I | Active |
| Incup | 10-5SPCA-384 | FDA UDI | Class II | Active |
| Incup | 10-9TC-030-S | FDA UDI | Class II | Active |
| RTCII 2nd gen. | 10-8MOX3-030 | FDA UDI | U | Unknown |
| RTCII 1st gen. | 10-5PX2B-200 | FDA UDI | Class II | Active |
| Rapid ONE | 10-THCS-000 | FDA UDI | Class I | Active |
| Incup | 10-9SPCA-267 | FDA UDI | Class II | Active |
| Rds | 10-10SPB-240 | FDA UDI | Class II | Active |
| Rds | 10-7SPA-152 | FDA UDI | Class II | Active |
| RTCII 2nd gen. | 10-8ABX3KE-030 | FDA UDI | U | Unknown |
| RTCII 2nd gen. | 10-9MOX3K2-030 | FDA UDI | U | Unknown |
| Rds | 10-4MS-030 | FDA UDI | Class II | Active |
| RTCII 1st gen. | 10-10XX2-030 | FDA UDI | Class II | Active |
| Rapid TOX | 10-OPIT-200 | FDA UDI | Class I | Active |
| Rds | 10-2CS-000 | FDA UDI | Class II | Active |
| Rapid TOX | 10-5ZT-030 | FDA UDI | U | Active |
| Rapid TOX | 10-6STA3-200 | FDA UDI | Class I | Active |
| Rapid TOX | 10-5MZT-030 | FDA UDI | U | Active |
| Incup | 10-4BC-030 | FDA UDI | Class II | Active |
| Incup | 10-7ZC-030 | FDA UDI | Class II | Active |
| Incup | 10-6SPCA-004-S | FDA UDI | Class II | Active |
| Rapid ONE | 10-THCC-000 | FDA UDI | Class I | Active |
| Rds | 10-7SP-307 | FDA UDI | Class II | Active |
| RTCII 1st gen. | 10-6SX2A-030 | FDA UDI | Class II | Active |
| Rds | 10-10DOS-000 | FDA UDI | Class II | Active |
| Rds | 10-7SPB-255 | FDA UDI | Class II | Active |
| Rds | 10-4BS-030 | FDA UDI | Class II | Active |
| Rds | 10-4AS-030 | FDA UDI | Class II | Active |
| Rds | 10-10DO1-000 | FDA UDI | Class II | Active |
| Rds | 10-2CMS-000 | FDA UDI | Class II | Active |
| Rds | 10-4OS-030 | FDA UDI | Class II | Active |
| RTCII 1st gen. | 10-10XX2B-030 | FDA UDI | Class II | Active |
| RTCII 1st gen. | 10-5PX2A-200 | FDA UDI | Class II | Active |
| Rapid ONE | 10-OPIS-000 | FDA UDI | U | Active |
| Rds | 10-9SPB-145 | FDA UDI | Class II | Active |
| RTCII 2nd gen. | 10-12BOX3-030 | FDA UDI | U | Unknown |
| RTCII 1st gen. | 10-10SPX2AB-339 | FDA UDI | Class II | Active |
| Incup | 10-6SC-030 | FDA UDI | Class II | Active |
| Rapid TOX | 10-8BT-530 | FDA UDI | U | Active |
| Rds | 10-5PS-030 | FDA UDI | Class II | Active |
| RTCII 2nd gen. | 10-13BOX3K2-030 | FDA UDI | U | Unknown |
| Incup | 10-5MCA-030 | FDA UDI | Class II | Active |
| Rds | 10-5M1-030 | FDA UDI | Class II | Active |
| Rapid TOX | 10-THCT-000 | FDA UDI | Class I | Active |
| Rds | 10-3O1-000 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.