Identity
- Trade Name
- ASI CRP Control Set FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, control FDA UDI
- Device Name
- Detection of C-Reactive Protein FDA UDI
- Model / Reference
- NC-505001 FDA UDI
- Description
- Detection of C-Reactive Protein FDA UDI
Identifiers
- Catalog Number
- NC-505001 FDA UDI
- Primary DI / UDI-DI
- 00816057021628 FDA UDI
- 510(k) Number
- K821388 FDA UDI
- FDA Product Code
- DCN FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, control 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: C-reactive protein (CRP) IVD, control
ASI CRP Control Set by Arlington Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as C-reactive protein (CRP) IVD, control.
- K-ASSAY® hsCRP Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
- HIGH SENSITIVITY CRP CONTROL - LEVEL II (hsCRP CONTROL 2) — Randox Laboratories, Ltd. · Class I
- Audit MicroControls Linearity LQ hs-CRP — Aalto Scientific, Ltd.
- Diazyme — Diazyme Laboratories, Inc.
- POINTE SCIENTIFIC CRP Control Set — POINTE SCIENTIFIC, INC. · Class II
- IMMULITE® Systems CRP CONTROL C-Reactive Protein — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- DImension Vista® High Sensitivity CRP Control H (high) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class I
Cleared under the same submission
K821388 also covers:
- ASI CRP Slide Test — Arlington Scientific, Inc.
- ASI CRP Slide Test — Arlington Scientific, Inc.
- ASI CRP Slide Test — Arlington Scientific, Inc.
- ASI CRP Slide Test — Arlington Scientific, Inc.
- ASI CRP Slide Test — Arlington Scientific, Inc.
- ASI CRP Slide Test — Arlington Scientific, Inc.
- ASI CRP Slide Test — Arlington Scientific, Inc.
- ASI Disposable Test Card — Arlington Scientific, Inc.
- ASI Disposable Test Card — Arlington Scientific, 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
- Arlington Scientific, Inc.
Sources (1)
- FDA UDI 2d333ffd-bfdf-4520-bb32-fd6ff4778786 38 fields · synced Jul 18, 2026