Identity
- Trade Name
- Cystatin C AMR Fluid FDA UDI
- Generic Name
- Cystatin C IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- BP514 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700016254 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Cystatin C IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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: Cystatin C IVD, kit, nephelometry/turbidimetry
Cystatin C AMR Fluid by The Binding Site Group — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cystatin C IVD, kit, nephelometry/turbidimetry.
- N Latex Cystatin C — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Diazyme — Diazyme Laboratories, Inc.
- Diazyme — Diazyme Laboratories, Inc.
- ADVIA Chemistry Cystatin C_2 Assay — Siemens Healthcare Diagnostics · Class II
- Diazyme — Diazyme Laboratories, Inc.
- N Latex Cystatin C — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Cystatin C — Sentinel Ch. Srl · Class II
- Tina-quant Cystatin C Gen.2 — Roche Diagnostics Corp. · 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
- The Binding Site Group
Sources (1)
- FDA UDI 39e1f6c4-c763-47be-b7df-16449ac73686 34 fields · synced May 30, 2026