Chrysalis Intelligence · Product Codes · DKZ

DKZ · Unclassified

4 clearances · 4 unique sponsors

Device class
Regulation —
Total clearances
4
2020-03-11 → 2024-10-30
Last 12 months
0
Unique sponsors
4
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Hangzhou AllTest Biotech Co., Ltd. 1 0 2023-12-13
Xenta Biomedical Science Co., Ltd. 1 0 2023-05-19
Quidel Cardiovascular, Inc. 1 0 2020-03-11
Microgenics Corporation 1 0 2024-10-30
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 covers drug screening by immunoassay including amphetamines
80325 CPT Medium Alternative amphetamine quantitation code depending on clinical context
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2024-10-30 K240670 Microgenics Corporation DRI Ecstasy Plus Assay
2023-12-13 K233019 Hangzhou AllTest Biotech Co., Ltd. AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
2023-05-19 K231137 Xenta Biomedical Science Co., Ltd. Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
2020-03-11 K200363 Quidel Cardiovascular, Inc. Quidel Triage® TOX Drug Screen, 94600