Identity
- Trade Name
- Genemed® FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, antibody FDA UDI
- Device Name
- anti-Human Chorionic Gonadotropin (hCG) Rabbit Polyclonal Antibody, Concentrate, 1 mL FDA UDI
- Model / Reference
- 61-0125 FDA UDI
- Description
- anti-Human Chorionic Gonadotropin (hCG) Rabbit Polyclonal Antibody, Concentrate, 1 mL FDA UDI
Identifiers
- Catalog Number
- 61-0125 FDA UDI
- Primary DI / UDI-DI
- 00615233003751 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 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
Category: Total human chorionic gonadotropin IVD, antibody
Genemed® by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total human chorionic gonadotropin IVD, antibody.
- hCG Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
- hCG Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
- hCG Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
- FLEX Poly Rb A-Hu Chorionic Gonadotropin RTU — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- FLEX Poly Rb A-Hu Chorionic Gonadotropin RTU (Link) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Poly Rb A-Hu Chorionic Gonadotropin — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- hCG Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
- ANTI-BETA-HCG — Biogenex Laboratories, 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
- Sakura Finetek USA, Inc
Sources (1)
- FDA UDI 8da58474-7a36-423a-9d43-f003a2a3f4df 35 fields · synced May 31, 2026