Identity
- Trade Name
- Monobind AccuLite hCG CLIA Kit - 192 Wells FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 875-300 FDA UDI
Identifiers
- Catalog Number
- 875-300B FDA UDI
- Primary DI / UDI-DI
- 00816870022598 FDA UDI
- FDA Product Code
- DHA FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 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
No
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
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: Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay
Monobind AccuLite hCG CLIA Kit - 192 Wells by Monobind, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay.
- VITROS — Ortho-Clinical Diagnostics · Class II
- IMMULITE® 2000 Systems HCG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Elecsys HCG+beta — Roche Diagnostics Corp. · Class II
- Elecsys HCG Test System — Roche Diagnostics Corp. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- ADVIA Centaur® ThCG — Siemens Healthcare Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- iFlash-HCG — Shenzhen YHLO Biotech Co., Ltd. · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Monobind, Inc.
Sources (1)
- FDA UDI cdccb408-edea-48b9-8bf2-c8c9a68c5fb9 36 fields · synced May 30, 2026