Identity
- Trade Name
- Monobind AccuBind 17OHP-SI ELISA Kit - 96 Wells FDA UDI
- Generic Name
- 17-Hydroxyprogesterone IVD, kit, radioimmunoassay FDA UDI
- Model / Reference
- 9925-300 FDA UDI
Identifiers
- Catalog Number
- 9925-300A FDA UDI
- Primary DI / UDI-DI
- 00816870021454 FDA UDI
- FDA Product Code
- JLX FDA UDI
- GMDN Term
- 17-Hydroxyprogesterone IVD, kit, radioimmunoassay FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1395 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: 17-Hydroxyprogesterone IVD, kit, radioimmunoassay
Monobind AccuBind 17OHP-SI ELISA Kit - 96 Wells by Monobind, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as 17-Hydroxyprogesterone IVD, kit, radioimmunoassay.
- MP Biomedicals LLC — MP BIOMEDICALS, LLC · Class I
- 17OHP RIA CT — Diasource Immunoassays, S.A. · 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
- Monobind, Inc.
Sources (1)
- FDA UDI 3a795974-5279-4188-8c28-d0851c4ef026 36 fields · synced Jun 6, 2026