Identity
- Trade Name
- Urine Calibrator Set FDA UDI
- Generic Name
- Ethyl glucuronide (EtG) IVD, calibrator FDA UDI
- Device Name
- 6PLUS1® Multilevel Urine Calibrator Set MassChrom® Ethyl Glucuronide, Ethyl Sulfate FDA UDI
- Model / Reference
- 69039 FDA UDI
- Description
- 6PLUS1® Multilevel Urine Calibrator Set MassChrom® Ethyl Glucuronide, Ethyl Sulfate FDA UDI
Identifiers
- Catalog Number
- 69039 FDA UDI
- Primary DI / UDI-DI
- 04250317536754 FDA UDI
- FDA Product Code
- DNN FDA UDI
- GMDN Term
- Ethyl glucuronide (EtG) 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
No
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
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: Ethyl glucuronide (EtG) IVD, calibrator
Urine Calibrator Set by Chromsystems Instruments & Chemicals GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ethyl glucuronide (EtG) IVD, calibrator.
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- Immunalysis — Immunalysis Corporation · Class II
- ARK™ Ethyl Glucuronide Calibrator — ARK DIAGNOSTICS INC · Class II
- ARK™ Ethyl Glucuronide Negative Calibrator — ARK DIAGNOSTICS INC · Class II
- Immunalysis — Immunalysis Corporation · Class I
- Immunalysis — Immunalysis Corporation · 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 |
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Manufacturer
- Manufacturer
- Chromsystems Instruments & Chemicals GmbH
Sources (1)
- FDA UDI eb94ddaa-0a43-444f-9a9a-b89b2b30bee3 37 fields · synced May 29, 2026