Identity
- Trade Name
- QMedix™ FDA UDI
- Generic Name
- Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- QMedix™T4 ELISA kit is intended to be used to quantitatively measure total thyroxine (TT4) in a clinical specimen, using an enzyme immunoassay (EIA) method. FDA UDI
- Model / Reference
- DACD3149-15 FDA UDI
- Description
- QMedix™T4 ELISA kit is intended to be used to quantitatively measure total thyroxine (TT4) in a clinical specimen, using an enzyme immunoassay (EIA) method. FDA UDI
Identifiers
- Catalog Number
- 3149-15 FDA UDI
- Primary DI / UDI-DI
- 00850054026484 FDA UDI
- FDA Product Code
- CDX FDA UDI
- GMDN Term
- Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1700 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
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
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: Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)
QMedix™ by Diagnostic Automation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Diagnostic Automation, Inc.
Sources (1)
- FDA UDI fbc4a62c-74c7-40ad-bac6-1106faeca43d 37 fields · synced May 30, 2026