Identity
- Trade Name
- Sperm Antibody ELISA FDA UDI
- Generic Name
- Sperm antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRG Sperm Antibody (seminal plasma) ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of antibodies directed against human spermatozoa in seminal plasma. FDA UDI
- Model / Reference
- EIA-4249 FDA UDI
- Description
- The DRG Sperm Antibody (seminal plasma) ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of antibodies directed against human spermatozoa in seminal plasma. FDA UDI
Identifiers
- Catalog Number
- EIA-4249 FDA UDI
- Primary DI / UDI-DI
- 04048474042498 FDA UDI
- FDA Product Code
- DFQ FDA UDI
- GMDN Term
- Sperm antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.5800 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: Sperm antibody IVD, kit, enzyme immunoassay (EIA)
Sperm Antibody 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 Sperm antibody IVD, kit, enzyme immunoassay (EIA).
- Sperm Antibody ELISA — Diasource Immunoassays, S.A. · Class I
- Sperm Antibody ELISA — DRG International, Inc. · Class I
- Sperm Antibody ELISA — DRG International, Inc. · Class I
- Sperm Antibody ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · 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
Sources (1)
- FDA UDI 0ca5dae0-6d24-4052-ad7c-58efab63fa85 36 fields · synced Jun 8, 2026