Identity
- Trade Name
- FSH ELISA FDA UDI
- Generic Name
- Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRG FSH ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Follicle Stimulating Hormone (FSH) in serum. FDA UDI
- Model / Reference
- EIA-1288 FDA UDI
- Description
- The DRG FSH ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Follicle Stimulating Hormone (FSH) in serum. FDA UDI
Identifiers
- Catalog Number
- EIA-1288 FDA UDI
- Primary DI / UDI-DI
- 04048474012880 FDA UDI
- FDA Product Code
- CGJ FDA UDI
- GMDN Term
- Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Category: Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA)
Fsh Elisa by DRG Instruments Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA).
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class I
- VIDAS® FSH — BIOMERIEUX , INC. · Class I
- Ansh Labs DBS Follicle-Stimulating Hormone ELISA — Ansh Labs, LLC
- FSH ELISA — DRG International, Inc. · Class I
- FSH — DRG International, Inc. · Class I
- FSH AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class I
- FSH ELISA — DRG International, Inc. · Class I
- FSH AccuBind ELISA 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
Sources (1)
- FDA UDI c532f69c-c800-46a6-9cb0-400a68efb778 36 fields · synced Jun 6, 2026