Identity
- Trade Name
- Detector C-Reactacol FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, precipitation/immunodiffusion FDA UDI
- Device Name
- A rapid color enhanced latex slide test for the detection of C-Reactive Protein FDA UDI
- Model / Reference
- CRC-100 FDA UDI
- Description
- A rapid color enhanced latex slide test for the detection of C-Reactive Protein FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10722355001170 FDA UDI
- 510(k) Number
- K834390 FDA UDI
- FDA Product Code
- DCN FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, kit, precipitation/immunodiffusion FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5270 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: C-reactive protein (CRP) IVD, kit, precipitation/immunodiffusion
Detector C-Reactacol by Immunostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as C-reactive protein (CRP) IVD, kit, precipitation/immunodiffusion.
- ASI CRP Slide Test — Arlington Scientific, Inc. · Class II
- AIM CRP TEST — GERMAINE LABORATORIES, INC. · Class II
- ASI CRP Slide Test — Arlington Scientific, Inc. · Class II
- C Reactive Protein RID plate package — KENT LABORATORIES, INC. · Class I
- ASI CRP Slide Test — Arlington Scientific, Inc. · Class II
- Antiserum to Human C Reactive Protein — KENT LABORATORIES, INC. · Class II
- Human C-Reactive Protein ‘EL’ NANORID Radial Immunodiffusion Kit — The Binding Site Group
- ASI CRP Slide Test — Arlington Scientific, Inc. · Class II
Cleared under the same submission
K834390 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 |
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Manufacturer
- Manufacturer
- Immunostics, Inc.
Sources (1)
- FDA UDI 5d6cf5dc-caf8-47a6-8e01-c8f44482b555 36 fields · synced Jun 8, 2026