Identity
- Trade Name
- 17OHP AccuLite CLIA Test System - 192 Wells FDA UDI
- Generic Name
- 17-Hydroxyprogesterone IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 5275-300 FDA UDI
Identifiers
- Catalog Number
- 5275-300B FDA UDI
- Primary DI / UDI-DI
- 00816870022888 FDA UDI
- FDA Product Code
- JLX FDA UDI
- GMDN Term
- 17-Hydroxyprogesterone IVD, kit, chemiluminescent immunoassay 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
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: 17-Hydroxyprogesterone IVD, kit, chemiluminescent immunoassay
17OHP 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 17-Hydroxyprogesterone IVD, kit, chemiluminescent immunoassay.
- 17 OH-Progesterone ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- 17 OH Progesterone ELISA — DRG International, Inc. · Class I
- Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA — DRG International, Inc. · Class I
- Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- 17OHP AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class I
- Monobind AccuLite 17OHP-SI CLIA Kit - 192 Wells — MONOBIND, INC. · Class I
- 17OHP-SI AccuLite CLIA Test System - 96 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 |
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Manufacturer
- Manufacturer
- Monobind, Inc.
Sources (1)
- FDA UDI db72656d-9eba-4be1-bd02-309beb24dd03 36 fields · synced May 29, 2026