Identity
- Trade Name
- Monobind AccuBind SHBG ELISA Kit - 96 Wells FDA UDI
- Generic Name
- Sex hormone binding globulin (SHBG) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 9125-300 FDA UDI
Identifiers
- Catalog Number
- 9125-300A FDA UDI
- Primary DI / UDI-DI
- 00816870021478 FDA UDI
- FDA Product Code
- CDZ FDA UDI
- GMDN Term
- Sex hormone binding globulin (SHBG) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1680 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 — 7.75 Inch FDA UDI
Category: Sex hormone binding globulin (SHBG) IVD, kit, enzyme immunoassay (EIA)
Monobind AccuBind SHBG ELISA Kit - 96 Wells by Monobind, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sex hormone binding globulin (SHBG) IVD, kit, enzyme immunoassay (EIA).
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 |
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Manufacturer
- Manufacturer
- Monobind, Inc.
Sources (1)
- FDA UDI 225403c1-b055-4e9c-b4a0-2b1480a88138 36 fields · synced May 30, 2026