Identity
- Trade Name
- Optilite IgA1 Kit FDA UDI
- Generic Name
- Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
- Model / Reference
- NK087.OPT.A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700017657 FDA UDI
- 510(k) Number
- K100588 FDA UDI
- FDA Product Code
- CFN FDA UDI
- GMDN Term
- Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 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: Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry
Optilite IgA1 Kit by The Binding Site Group — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry.
- Dimension® Flex® reagent cartridge IGA — Siemens Healthcare Diagnostics · Class II
- Human IgA2 Subclass Liquid Latex Reagent Kit for use on the Siemens BN™II — The Binding Site Group · Class II
- Optilite IgA2 Kit — The Binding Site Group · Class II
- Human IgA1 Subclass BNII Kit — The Binding Site Group · Class II
Cleared under the same submission
K100588 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (2)
- FDA UDI 0764a456-c2d2-429a-9c2d-afd3c9938fe1 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026