Identity
- Trade Name
- Easy Talk FDA UDI
- Generic Name
- Glucose IVD, control FDA UDI
- Device Name
- Easy Talk Control Solution-Low(Box) FDA UDI
- Model / Reference
- GOD11(BZL002HA) FDA UDI
- Description
- Easy Talk Control Solution-Low(Box) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719871820209 FDA UDI
- FDA Product Code
- CGA FDA UDIJJX FDA UDINBW FDA UDI
- GMDN Term
- Glucose IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1345 FDA UDI862.1660 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Convenience Kit
No
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
Easy Talk by Biotest Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Biotest Medical Corporation
Sources (1)
- FDA UDI 55378853-abd2-4e11-9bff-c57c253d0050 34 fields · synced Jun 1, 2026