Identity
- Trade Name
- RTCII 2nd gen. FDA UDI
- Generic Name
- Multiple therapeutic drugs/drugs of abuse IVD, calibrator FDA UDI
- Device Name
- RTC II 2ND GEN COC150/METH500/OPI300/AMP500/PCP/BZO/BAR/BUP/OXY/MDMA500/MTD FDA UDI
- Model / Reference
- 10-11MBZ3-030 FDA UDI
- Description
- RTC II 2ND GEN COC150/METH500/OPI300/AMP500/PCP/BZO/BAR/BUP/OXY/MDMA500/MTD FDA UDI
Identifiers
- Catalog Number
- 10-11MBZ3-030 FDA UDI
- Primary DI / UDI-DI
- 10694644500391 FDA UDI
- 510(k) Number
- K170222 FDA UDI
- FDA Product Code
- DJR FDA UDILFG FDA UDILAF FDA UDIDKZ FDA UDIDIO FDA UDIDIS FDA UDIDJG FDA UDIJXM FDA UDILCM FDA UDILDJ FDA UDI
- GMDN Term
- Multiple therapeutic drugs/drugs of abuse IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3620 FDA UDI862.3910 FDA UDI862.3610 FDA UDI862.3100 FDA UDI862.3250 FDA UDI862.3150 FDA UDI862.3650 FDA UDI862.3170 FDA UDI862.3870 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
Yes
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
RTCII 2nd gen. 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.
- RDS — American Bio Medica Corp. · Class II
- RDS — American Bio Medica Corp. · Class II
- RTCII 1st gen. — American Bio Medica Corp. · Class II
- RTCII 2nd gen. — American Bio Medica Corp. · Class II
- Rapid TOX — American Bio Medica Corp. · U
- RTCII 1st gen. — American Bio Medica Corp. · Class II
- RTCII 1st gen. — American Bio Medica Corp. · Class II
- RDS — American Bio Medica Corp. · Class II
Cleared under the same submission
K170222 also covers:
- RTCII 2nd gen. — American Bio Medica Corp.
- RTCII 2nd gen. — American Bio Medica Corp.
- RTCII 2nd gen. — American Bio Medica Corp.
- RTCII 2nd gen. — American Bio Medica Corp.
- RTCII 2nd gen. — American Bio Medica Corp.
- RTCII 2nd gen. — American Bio Medica Corp.
- RTCII 2nd gen. — American Bio Medica Corp.
- RTCII 2nd gen. — American Bio Medica Corp.
- RTCII 2nd gen. — American Bio Medica Corp.
- RTCII 2nd gen. — American Bio Medica Corp.
- RTCII 2nd gen. — American Bio Medica Corp.
- RTCII 2nd gen. — American Bio Medica Corp.
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 II | Pending data |
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Manufacturer
- Manufacturer
- American Bio Medica Corp.
Sources (1)
- FDA UDI d1eea2ef-d2c4-4312-980d-29c7f34726b4 37 fields · synced Jun 6, 2026