Identity
- Trade Name
- IMMCO DIAGNOSTICS FDA UDI
- Generic Name
- Multiple antinuclear antibody (ANA) screening IVD, reagent FDA UDI
- Device Name
- Mouse Kidney / Stomach Slide FDA UDI
- Model / Reference
- 2152 FDA UDI
- Description
- Mouse Kidney / Stomach Slide FDA UDI
Identifiers
- Catalog Number
- 2152 FDA UDI
- Primary DI / UDI-DI
- 00845714001987 FDA UDI
- 510(k) Number
- K883915 FDA UDI
- FDA Product Code
- DBL FDA UDI
- GMDN Term
- Multiple antinuclear antibody (ANA) screening IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 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: Multiple antinuclear antibody (ANA) screening IVD, reagent
Immco Diagnostics by Immco Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple antinuclear antibody (ANA) screening IVD, reagent.
- Autoimmune EIA — Bio-Rad Laboratories · Class II
- HEp-2000® IgG Fluorescent ANA-Ro Test System — IMMUNO CONCEPTS INC
- HEp-2000® IgG Fluorescent ANA-Ro Test System — IMMUNO CONCEPTS INC
- Kallestad — Bio-Rad Laboratories · Class II
- HEp-2000® IgG Fluorescent ANA-Ro Test System — IMMUNO CONCEPTS INC
- ANA PLATE — Bio-Rad Laboratories · Class II
- Autoimmune EIA — Bio-Rad Laboratories · Class II
- Colorzyme® ANA Test System — IMMUNO CONCEPTS INC
Cleared under the same submission
K883915 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.
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immco Diagnostics, Inc.
Sources (1)
- FDA UDI 9bdb4ef5-91a6-4d9a-9d53-4950f0b1b29e 38 fields · synced Sep 17, 2026