Identity
- Trade Name
- IgG4 (M) FDA UDI
- Generic Name
- Adenovirus immunoglobulin G (IgG) antibody IVD, reagent FDA UDI
- Model / Reference
- ACI3115A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627003003 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Adenovirus immunoglobulin G (IgG) antibody IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 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
No
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: Adenovirus immunoglobulin G (IgG) antibody IVD, reagent
IgG4 (M) by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Adenovirus immunoglobulin G (IgG) antibody IVD, reagent.
- Adenovirus Antigen Substrate, 12 wells, For IFA Test System — BION ENTERPRISES, LTD. · Class I
- IgG4 (M) — BIOCARE MEDICAL, LLC · Class I
- IgG4 (M) — BIOCARE MEDICAL, LLC · 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
- Biocare Medical, Llc
Sources (1)
- FDA UDI 41437f0d-1ca0-4c2d-a53d-838324fdde64 33 fields · synced May 30, 2026