Identity
- Trade Name
- Monobind Qsure TBG Control Set FDA UDI
- Generic Name
- Thyroxine binding globulin (TBG) IVD, control FDA UDI
- Model / Reference
- TBG-300 FDA UDI
Identifiers
- Catalog Number
- TBG-300 FDA UDI
- Primary DI / UDI-DI
- 00816870020181 FDA UDI
- FDA Product Code
- JJY FDA UDI
- GMDN Term
- Thyroxine binding globulin (TBG) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 2 Inch FDA UDI
Category: Thyroxine binding globulin (TBG) IVD, control
Monobind Qsure TBG Control Set by Monobind, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thyroxine binding globulin (TBG) IVD, control.
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Monobind, Inc.
Sources (1)
- FDA UDI b6f1e7a9-ea72-40a6-9ee0-74ad9010957b 36 fields · synced May 30, 2026