Identity
- Trade Name
- Detector Color IM FDA UDI
- Generic Name
- Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination FDA UDI
- Device Name
- A simple color enhanced slide test for the detection of infectious mononucleosis FDA UDI
- Model / Reference
- IMC-100 FDA UDI
- Description
- A simple color enhanced slide test for the detection of infectious mononucleosis FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10722355001217 FDA UDI
- 510(k) Number
- K861016 FDA UDI
- FDA Product Code
- KTN FDA UDI
- GMDN Term
- Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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: Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination
Detector Color IM by Immunostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination.
- ASI Color Mono II Control Set — Arlington Scientific, Inc. · Class II
- Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- Wampole ColorCard® Mono — ALERE NORTH AMERICA, LLC · Class II
- ASI Color Mono II Test — Arlington Scientific, Inc. · Class II
- Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- ASI Color Mono II Test — Arlington Scientific, Inc. · Class II
Cleared under the same submission
K861016 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immunostics, Inc.
Sources (1)
- FDA UDI 590f1554-bbac-47e3-a6bf-12b6578b6435 36 fields · synced May 30, 2026