Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- ARCHITECT FSH Reagent Kit (500T) FDA UDI
- Model / Reference
- 7K75-35 FDA UDI
- Description
- ARCHITECT FSH Reagent Kit (500T) FDA UDI
Identifiers
- Catalog Number
- 07K7535 FDA UDI
- Primary DI / UDI-DI
- 00380740105983 FDA UDI
- FDA Product Code
- CGJ FDA UDI
- GMDN Term
- Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1300 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Architect by Abbott Ireland — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay.
- Elecsys FSH — Roche Diagnostics Corp. · Class I
- FSH AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class I
- Elecsys FSH — Roche Diagnostics Corp. · Class I
- Monobind AccuLite FSH, hCG, LH & PRLs VAST CLIA Kit - 480 Wells — MONOBIND, INC. · Class I
- LIAISON FSH — Diasorin Inc.
- IMMULITE® 2000 Systems FSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- IMMULITE 2000 FSH Kit Domestic 200T — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Monobind AccuLite FSH, hCG, LH & PRLs VAST CLIA Kit - 960 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 Ireland
Sources (1)
- FDA UDI 9b0dcfd2-5200-43a3-b72f-258365d3fafc 36 fields · synced May 30, 2026