Identity
- Trade Name
- ASI Sickle Cell Test FDA UDI
- Generic Name
- Haemoglobin S (HbS) IVD, reagent FDA UDI
- Device Name
- Detection of the presence of Hgb-S for Export FDA UDI
- Model / Reference
- NC-200025E FDA UDI
- Description
- Detection of the presence of Hgb-S for Export FDA UDI
Identifiers
- Catalog Number
- NC-200025E FDA UDI
- Primary DI / UDI-DI
- 00816057020010 FDA UDI
- FDA Product Code
- GHM FDA UDI
- GMDN Term
- Haemoglobin S (HbS) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7825 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
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: Haemoglobin S (HbS) IVD, reagent
ASI Sickle Cell Test by Arlington Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemoglobin S (HbS) IVD, reagent.
- Sickle-Heme — GREAT LAKES DIAGNOSTICS, INC. · Class II
- anti-HbS PURE — IQ Products B.V. · Class I
- SAS Sickle Cell Test — SA SCIENTIFIC, LTD
- Ritter Dental Implant System — Ritter Implants GmbH CO KG · Class II
- Sickle-Heme — GREAT LAKES DIAGNOSTICS, INC. · Class II
- Sickle-Heme — GREAT LAKES DIAGNOSTICS, INC. · Class II
- anti-HbS FITC — IQ Products B.V. · Class I
- Dade® Sickle-Sol Test — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
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
- Arlington Scientific, Inc.
Sources (1)
- FDA UDI e6bb4727-a3e3-449b-98d0-2876e2b0b8a4 37 fields · synced Jul 18, 2026