Identity
- Trade Name
- Diptheria Toxoid IgG Calibrator Set FDA UDI
- Generic Name
- Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- EA068.A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051700020985 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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
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: Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Diptheria Toxoid IgG Calibrator Set by The Binding Site Group — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Corynebacterium diphtheriae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- Cornybacterium diphtheriae toxin IgG ELISA — DRG International, Inc. · Class I
- Cornybacterium diphtheriae toxin IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Diptheria Toxoid IgG Low Control — The Binding Site Group · Class I
- Diptheria Toxoid IgG High Control — The Binding Site Group · 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 c16cbc67-4b78-4f80-a4a2-fbeccd8c8f7a 34 fields · synced May 30, 2026