Identity
- Trade Name
- Progesterone AccuLite CLIA Test System - 192 Wells FDA UDI
- Generic Name
- Progesterone IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 4875-300 FDA UDI
Identifiers
- Catalog Number
- 4875-300B FDA UDI
- Primary DI / UDI-DI
- 00816870022864 FDA UDI
- FDA Product Code
- JLS FDA UDI
- GMDN Term
- Progesterone IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1620 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: Progesterone IVD, kit, chemiluminescent immunoassay
Progesterone AccuLite CLIA Test System - 192 Wells by Monobind, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Progesterone IVD, kit, chemiluminescent immunoassay.
- Progesterone (serum) — DRG International, Inc. · Class I
- Dimension Vista® Flex® reagent cartridge PROG — Siemens Healthcare Diagnostics · Class I
- VITROS — Ortho-Clinical Diagnostics · Class I
- IMMULITE® 2000 Systems PRG Progesterone — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Progesterone Luminescence Immunoassay — IBL International GmbH · Class I
- Alinity — ABBOTT IRELAND · Class I
- Elecsys Progesterone III — Roche Diagnostics Corp. · Class I
- iFlash-Progesterone — Shenzhen YHLO Biotech Co., 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 3e5d2e9f-4863-42dd-ac73-4cd85b175973 36 fields · synced May 30, 2026