Identity
- Trade Name
- Optilite® Low Level IgG Control Pack FDA UDI
- Generic Name
- Total immunoglobulin G (IgG total) IVD, control FDA UDI
- Model / Reference
- NQ004.LL.OPT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700019033 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Total immunoglobulin G (IgG total) IVD, control 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
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: Total immunoglobulin G (IgG total) IVD, control
Optilite® Low Level IgG Control Pack by The Binding Site Group — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Total immunoglobulin G (IgG total) IVD, control.
- IgG control slides — BIO SB, INC. · Class I
- Negative Control Mo IgG2b — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Negative Control Rb Immunoglobulin Fraction (Solid-Phase Absorbed) — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- IgG RID Plate Kit — KENT LABORATORIES, INC. · Class II
- Antiserum to Human IgG (gamma chain specific) — KENT LABORATORIES, INC. · Class II
- Negative Control Mo IgG1/RPE-Cy5, Cl DAK-GO1 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class II
- IgG control slides — BIO SB, INC. · Class I
- Peroxidase conjugated Antiserum to Human IgG — KENT LABORATORIES, INC. · Class II
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- The Binding Site Group
Sources (2)
- FDA UDI 4de926b9-07a4-4548-83c9-3e00f02c2ac5 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026