Identity
- Trade Name
- Fibrinogen Control Slides FDA UDI
- Generic Name
- Fibrinogen assay (factor I) IVD, control FDA UDI
- Device Name
- Fibrinogen Control Slides FDA UDI
- Model / Reference
- BSB-9179-CS FDA UDI
- Description
- Fibrinogen Control Slides FDA UDI
Identifiers
- Catalog Number
- BSB-9179-CS FDA UDI
- Primary DI / UDI-DI
- B502BSB9179CS0 FDA UDI
- FDA Product Code
- LJG FDA UDI
- GMDN Term
- Fibrinogen assay (factor I) 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fibrinogen assay (factor I) IVD, control
Fibrinogen Control Slides by Bio Sb, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fibrinogen assay (factor I) IVD, control.
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- Dade® Data-Fi® Abnormal Fibrinogen Control — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- CRYOcheck™ Low Fibrinogen Control — Precision Biologic · Class II
- K-ASSAY® Fibrinogen Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Antiserum to Human Fibrinogen — KENT LABORATORIES, INC. · Class II
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
- Bio Sb, Inc.
Sources (1)
- FDA UDI 3042ad37-e735-4027-ab94-387b24387211 36 fields · synced Jun 6, 2026