Identity
- Trade Name
- FSH AccuLite CLIA Test System - 96 Wells FDA UDI
- Generic Name
- Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 475-300 FDA UDI
Identifiers
- Catalog Number
- 475-300A FDA UDI
- Primary DI / UDI-DI
- 00816870022567 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 7.75 Inch FDA UDI
Category: Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
FSH AccuLite CLIA Test System - 96 Wells by Monobind, Inc. — 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
- Elecsys FSH — Roche Diagnostics Corp. · Class I
- ARCHITECT — ABBOTT IRELAND · 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
- IMMULITE®/IMMULITE® 1000 Systems FSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- IMMULITE 2000 FSH Kit Domestic 600T — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Monobind, Inc.
Sources (1)
- FDA UDI 8b2e5cdf-a5dc-49ab-af94-3fb09668c62b 36 fields · synced May 30, 2026