Chrysalis Intelligence · Product Codes · DJG

DJG · Enzyme Immunoassay, Opiates

Clinical Toxicology · 31 clearances · 22 unique sponsors

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Device class
Class II
Regulation 862.3650
Total clearances
31
2020-02-26 → 2026-01-29
Last 12 months
3
Unique sponsors
22
Classification details
Medical specialty
Clinical Toxicology
Review panel
TX
Regulation number
862.3650
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Lin-Zhi International, Inc. 5 1 2026-01-16
Randox Laboratories Limited 3 1 2026-01-23
Guangzhou Decheng Biotechnology Co., Ltd. 2 0 2024-05-10
Ark Diagnostics, Inc. 2 0 2023-11-09
Immunalysis Corporation 2 0 2025-09-11
Assure Tech. (Hangzhou) Co, Ltd. 1 0 2021-08-12
Hangzhou AllTest Biotech Co., Ltd. 1 0 2023-07-31
Lmmunalysis Corporation 1 0 2022-05-09
Psychemedics Corporation 1 0 2021-07-27
Microgenics Corporation 1 0 2023-09-27
Shanghai Accurature Diagnostics Co., Ltd. 1 0 2024-02-23
Shenzhen Bioeasy Biotechnology Co., Ltd. 1 0 2023-03-31
Hangzhou Laihe Biotech Co., Ltd. 1 0 2024-01-09
Advin Biotech, Inc. 1 0 2020-09-17
Vivachek Biotech (Hangzhou) Co., Ltd. 1 0 2024-06-14
Healgen Scientific,, LLC 1 0 2025-08-15
Siemens Healthcare Diagnostics, Inc. 1 0 2023-07-25
Medtox Diagnostics, Inc. 1 1 2026-01-29
Co-Innovation Biotech Co., Ltd. 1 0 2024-03-08
Chemtron Biotech, Inc. 1 0 2023-12-20
Xenta Biomedical Science Co., Ltd. 1 0 2023-02-06
Shenzhen Superbio Technology Co., Ltd. 1 0 2022-12-13
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
80102 CPT — High CPT 80102 is the standard code for drug screen by immunoassay, including opiates
80307 CPT — Medium Alternative opioid quantitation code depending on clinical context
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-01-29 K252684 Medtox Diagnostics, Inc. Labcorp Fentanyl Urine Visual Test
2026-01-23 K250741 Randox Laboratories Limited Evidence MultiSTAT DOA Urine MultiPlex
2026-01-16 K253082 Lin-Zhi International, Inc. LZI Buprenorphine II Enzyme Immunoassay
2025-09-11 K252520 Immunalysis Corporation SEFRIA™ Hydrocodone Oral Fluid
2025-08-15 K251972 Healgen Scientific,, LLC Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)
2025-06-18 K251634 Lin-Zhi International, Inc. LZI Fentanyl III Enzyme Immunoassay
2024-06-14 K240124 Vivachek Biotech (Hangzhou) Co., Ltd. BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader
2024-05-10 K240698 Guangzhou Decheng Biotechnology Co., Ltd. Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard
2024-03-08 K231904 Co-Innovation Biotech Co., Ltd. Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
2024-02-23 K232228 Shanghai Accurature Diagnostics Co., Ltd. Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card
2024-01-09 K232597 Hangzhou Laihe Biotech Co., Ltd. LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)
2023-12-20 K232736 Chemtron Biotech, Inc. Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test
2023-12-13 K232659 Guangzhou Decheng Biotechnology Co., Ltd. Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
2023-11-09 K231752 Ark Diagnostics, Inc. ARK Hydrocodone Assay
2023-10-05 K221550 Randox Laboratories Limited Evidence MultiSTAT DOA Urine MultiPlex
2023-10-05 K220451 Randox Laboratories Limited Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
2023-09-27 K231007 Microgenics Corporation CEDIA Heroin Metabolite (6-AM) Assay
2023-07-31 K231698 Hangzhou AllTest Biotech Co., Ltd. AllTest Fentanyl Rapid Test (Urine)
2023-07-25 K221605 Siemens Healthcare Diagnostics, Inc. Emit® II Plus Buprenorphine Assay
2023-03-31 K230238 Shenzhen Bioeasy Biotechnology Co., Ltd. BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx
2023-02-06 K222955 Xenta Biomedical Science Co., Ltd. Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
2022-12-13 K220046 Shenzhen Superbio Technology Co., Ltd. Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11
2022-05-09 K203527 Lmmunalysis Corporation Immunalysis Tapentadol Urine HEIA
2021-12-22 K203564 Immunalysis Corporation SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
2021-08-12 K201630 Assure Tech. (Hangzhou) Co, Ltd. AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence