Identity
- Trade Name
- IMMCO DIAGNOSTICS FDA UDI
- Generic Name
- Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD FDA UDI
- Device Name
- IgG FITC Conjugate FDA UDI
- Model / Reference
- 2100X-8 FDA UDI
- Description
- IgG FITC Conjugate FDA UDI
Identifiers
- Catalog Number
- 2100X-8 FDA UDI
- Primary DI / UDI-DI
- 00845714003011 FDA UDI
- 510(k) Number
- K883949 FDA UDI
- FDA Product Code
- LKJ FDA UDI
- GMDN Term
- Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Immco Diagnostics by Immco Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD.
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- IGG — Medicon Hellas SA · Class B
- A-400 IgG — PZ CORMAY Spółka Akcyjna · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
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Cleared under the same submission
K883949 also covers:
- IMMCO DIAGNOSTIC — Immco Diagnostics, Inc.
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc.
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc.
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc.
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc.
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc.
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc.
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc.
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc.
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc.
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Immco Diagnostics, Inc.
Sources (1)
- FDA UDI 8a7b5c68-7879-435b-ae36-d3e88e427616 38 fields · synced Sep 17, 2026