Identity
- Trade Name
- Optilite Anti-Streptolysin-O Kit FDA UDI
- Generic Name
- Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- LK189.OPT.A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700017695 FDA UDI
- FDA Product Code
- GTQ FDA UDI
- GMDN Term
- Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3720 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
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: Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
Optilite Anti-Streptolysin-O Kit by The Binding Site Group — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry.
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- Dimension Vista®Antistreptolysin O Flex® reagent cartridge — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Anti-Streptolysin O (ASO) — Randox Laboratories, Ltd. · Class I
- ANTI-STREPTOLYSIN-O 2 (ASO 2) — Randox Laboratories, Ltd. · Class I
- ADVIA® Chemistry ASO_2 Anti-Streptolysin-O_2 Reagents — Siemens Healthcare Diagnostics · Class I
- N Latex ASL — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · 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 |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (1)
- FDA UDI 541ec19a-1a51-418b-adeb-822cdfbfdaf9 34 fields · synced May 30, 2026