Optilite Cystatin C Kit

FDA UDI

Class II (US FDA UDI)

by The Binding Site Group

Identity

Trade Name: Optilite Cystatin C Kit FDA UDI
Generic Name: Cystatin C IVD, kit, nephelometry/turbidimetry FDA UDI
Model / Reference: LK048.OPT.A FDA UDI

Identifiers

Primary DI / UDI-DI: 05051700017909 FDA UDI
510(k) Number: K072166 FDA UDI
FDA Product Code: NDY FDA UDI
GMDN Term: Cystatin C IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1225 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Cystatin C IVD, kit, nephelometry/turbidimetry

Optilite Cystatin C Kit by The Binding Site Group — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: The Binding Site Group

Sources (1)

FDA UDI 1dc12d0e-b911-4bda-a701-0a1e0747583c 35 fields · synced Jun 1, 2026