Identity
- Trade Name
- OSOM hCG Urine Ctrl Set FDA UDI
- Generic Name
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control FDA UDI
- Model / Reference
- 134 FDA UDI
Identifiers
- Catalog Number
- 134 FDA UDI
- Primary DI / UDI-DI
- 00742860100086 FDA UDI
- 510(k) Number
- K974159 FDA UDI
- FDA Product Code
- JHI FDA UDI
- GMDN Term
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 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
No
FDA UDI
Category: Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control
OSOM hCG Urine Ctrl Set by Sekisui Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control.
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- MedTest DX Elevated HCG Control Vial Label - B — Medtest DX · Class I
- MedTest DX HCG Control Set Level A — Medtest DX · Class I
- MedTest DX HCG Control Set Level B — Medtest DX · Class I
- HCG SERUM CONTROL KIT — Sekisui Diagnostics, LLC · Class I
Cleared under the same submission
K974159 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Sekisui Diagnostics, LLC
Sources (1)
- FDA UDI 29c0b4f3-698e-4dba-8a83-54dd5712638d 34 fields · synced Jun 9, 2026