Identity
- Trade Name
- HEMOSURE® FDA UDI
- Generic Name
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control FDA UDI
- Device Name
- Hemosure hCG Controls Set 2ml. FDA UDI
- Model / Reference
- F2-TC01 FDA UDI
- Description
- Hemosure hCG Controls Set 2ml. FDA UDI
Identifiers
- Catalog Number
- F2-TC01 FDA UDI
- Primary DI / UDI-DI
- 00857338006347 FDA UDI
- GMDN Term
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control FDA UDI
Classification
- 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
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
Hemosure® by Hemosure Inc. — 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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- HCG SERUM CONTROL KIT — Sekisui Diagnostics, LLC · Class I
- MedTest DX HCG Control Set Level A — Medtest DX · Class I
- MedTest DX HCG Control Set Level B — Medtest DX · 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Hemosure Inc.
Sources (1)
- FDA UDI 2aa7806e-ad36-49c2-b44e-156b7d967552 35 fields · synced May 30, 2026