Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Alinity i SHBG Reagent Kit FDA UDI
- Model / Reference
- 09P3820 FDA UDI
- Description
- Alinity i SHBG Reagent Kit FDA UDI
Identifiers
- Catalog Number
- 09P3820 FDA UDI
- Primary DI / UDI-DI
- 00380740151393 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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: Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay
Alinity by Abbott — 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.
- Elecsys SHBG — Roche Diagnostics Corp. · Class I
- SHBG AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class I
- Elecsys SHBG — Roche Diagnostics Corp. · Class I
- FastPack® IP SHBG — QUALIGEN INC. · Class I
- Atellica IM SHBG — Siemens Healthcare Diagnostics · Class I
- IMMULITE®/IMMULITE® 1000 Systems SBG SHBG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- FastPack® IP SHBG — QUALIGEN INC. · Class I
- SHBG AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class I
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
- Abbott
Sources (1)
- FDA UDI 39f57c56-6f83-4f2f-b2a4-150ddc860cb2 36 fields · synced May 30, 2026