Identity
- Trade Name
- hCG control slides FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, control FDA UDI
- Device Name
- hCG Control FDA UDI
- Model / Reference
- Control Slides, 5 FDA UDI
- Description
- hCG Control FDA UDI
Identifiers
- Catalog Number
- BSB5602 FDA UDI
- Primary DI / UDI-DI
- B502BSB56020 FDA UDI
- FDA Product Code
- LJG FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2660 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Total human chorionic gonadotropin IVD, control
hCG control slides by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total human chorionic gonadotropin IVD, control.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- MAGLUMI 2000 HCG/beta-HCG — Shenzhen New Industries Biomedical Engineering Co., Ltd. · Class II
- hCG Bi-Level Urine Controls — STANBIO LABORATORY, L.P. · Class I
- IMMULITE® Systems HCG CONTROL HCG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- AdexusDx hCG Control Set (unassayed) — NOWDIAGNOSTICS, INC. · Class I
- SAS hCG Serum Control Set — SA SCIENTIFIC, LTD
- SAS hCG Urine Control Set — SA SCIENTIFIC, LTD
- hCG Tri-Level Serum Controls — STANBIO LABORATORY, L.P. · 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
- Manufacturer
- Bio Sb, Inc.
Sources (1)
- FDA UDI 513c2c11-4506-4c93-8c83-68863e80715e 34 fields · synced May 30, 2026