Identity
- Trade Name
- Elecsys SHBG FDA UDI
- Generic Name
- Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 07258496190 FDA UDI
Identifiers
- Catalog Number
- 07258496190 FDA UDI
- Primary DI / UDI-DI
- 04015630940516 FDA UDI
- 510(k) Number
- K102814 FDA UDI
- FDA Product Code
- CDZ FDA UDI
- GMDN Term
- Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
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: Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay
Elecsys SHBG by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay.
- SHBG AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class I
- FastPack® IP SHBG — QUALIGEN INC. · Class I
- Alinity — Abbott · Class I
- Atellica IM SHBG — Siemens Healthcare Diagnostics · Class I
- IMMULITE®/IMMULITE® 1000 Systems SBG SHBG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- ARCHITECT — Abbott · Class I
- FastPack® IP SHBG — QUALIGEN INC. · Class I
- SHBG AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class I
Cleared under the same submission
K102814 also covers:
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 24cb956c-d6d7-4655-838a-b13214b088eb 35 fields · synced May 30, 2026