Identity
- Trade Name
- FastPack® IP SHBG FDA UDI
- Generic Name
- Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls FDA UDI
- Model / Reference
- FastPack® IP SHBG 30 Immunoassay FDA UDI
- Description
- 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls FDA UDI
Identifiers
- Catalog Number
- 25000081 FDA UDI
- Primary DI / UDI-DI
- 20816467020345 FDA UDI
- 510(k) Number
- K182521 FDA UDI
- FDA Product Code
- JJX FDA UDIJIT FDA UDICDZ FDA UDI
- GMDN Term
- Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI862.1150 FDA UDI862.1680 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
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
FastPack® IP SHBG by Qualigen 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, 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
- 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
- SHBG AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class I
Cleared under the same submission
K182521 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
- Qualigen Inc.
Sources (1)
- FDA UDI cf2e7782-8108-48fa-9c05-461197bd4732 37 fields · synced Jun 1, 2026