Identity
- Trade Name
- Immunalysis FDA UDI
- Generic Name
- 6-Acetyl morphine IVD, calibrator FDA UDI
- Device Name
- 6-Acetylmorphine Urine Calibrator FDA UDI
- Model / Reference
- 04Z41-01 FDA UDI
- Description
- 6-Acetylmorphine Urine Calibrator FDA UDI
Identifiers
- Catalog Number
- 04Z41-01 FDA UDI
- Primary DI / UDI-DI
- 00840937111321 FDA UDI
- FDA Product Code
- DKB FDA UDI
- GMDN Term
- 6-Acetyl morphine IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
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, calibrator
Immunalysis by Immunalysis Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as 6-Acetyl morphine IVD, calibrator.
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- Oral Fluid 6-Acetylmorphine Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc. · Class II
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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
- Immunalysis Corporation
Sources (1)
- FDA UDI 422a7a7f-b1e2-4a9e-a501-79e84b8adbe9 35 fields · synced Jun 1, 2026