Identity
- Trade Name
- IGF-1 AccuBind ELISA Test System - 192 Wells FDA UDI
- Generic Name
- Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 13325-300 FDA UDI
Identifiers
- Catalog Number
- 13325-300B FDA UDI
- Primary DI / UDI-DI
- 00816870024882 FDA UDI
- FDA Product Code
- CFL FDA UDI
- GMDN Term
- Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1370 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
No
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: Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA)
IGF-1 AccuBind ELISA Test System - 192 Wells by Monobind, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insulin-like growth factor I (IGF1) IVD, kit, enzyme immunoassay (EIA).
- Progesterone ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Ansh Labs Total IGF-I ELISA (IVD) — Ansh Labs, LLC
- IGF-1 ELISA — Diasource Immunoassays, S.A. · Class I
- IGF-1 600 ELISA — DRG International, Inc. · Class I
- IGF-1 600 ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Progesterone ELISA — DRG International, Inc. · Class I
- Ansh Labs Total IGF-I ELISA (CE) — Ansh Labs, LLC
- IGF-1 AccuLite CLIA Test System - 192 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Monobind, Inc.
Sources (1)
- FDA UDI 133a5860-8a0b-4964-b8e5-f9900fbfe6c7 36 fields · synced May 30, 2026