Identity
- Trade Name
- 6-Acetylmorphine Enzyme Immunoassay FDA UDI
- Generic Name
- 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 240 tests. c pack green, PCh Antibody/Substrate Reagent (R1): 1 x 24.0 mL Enzyme Conjugate Reagent (R2): 1 x 10.1 mL FDA UDI
- Model / Reference
- 09067795190 FDA UDI
- Description
- 240 tests. c pack green, PCh Antibody/Substrate Reagent (R1): 1 x 24.0 mL Enzyme Conjugate Reagent (R2): 1 x 10.1 mL FDA UDI
Identifiers
- Catalog Number
- 09067795190 FDA UDI
- Primary DI / UDI-DI
- 00850624008520 FDA UDI
- FDA Product Code
- DJG FDA UDI
- GMDN Term
- 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 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
No
FDA UDI
Convenience Kit
Yes
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: 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)
6-Acetylmorphine Enzyme Immunoassay by Lin-Zhi International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA).
- Syva® Emit® II Plus 6-Acetylmorphine Assay — Siemens Healthcare Diagnostics · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT ST325 — Carolina Liquid Chemistries Corp. · Class I
- Immunalysis — Immunalysis Corporation · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT AU-425 — Carolina Liquid Chemistries Corp. · Class I
- Syva® Emit® II Plus 6-Acetylmorphine Assay — Siemens Healthcare Diagnostics · Class II
- Pointe 6-Acetylmorphine Reagent Set — POINTE SCIENTIFIC, INC. · Class II
- Immunalysis — Immunalysis Corporation · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM REAGENT KIT Product No. DT425 — Carolina Liquid Chemistries Corp. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI 20319c92-dfb4-4f59-8fba-ae459fcec122 35 fields · synced Jun 9, 2026