Identity
- Trade Name
- JAS Diagnostics FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, spectrophotometry FDA UDI
- Device Name
- CRP (HS) (WR) CONTROL SET (1x 3mL L1, 1x 3mL L2) FDA UDI
- Model / Reference
- CRP3C-3 FDA UDI
- Description
- CRP (HS) (WR) CONTROL SET (1x 3mL L1, 1x 3mL L2) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817274021484 FDA UDI
- FDA Product Code
- DCK FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, kit, spectrophotometry 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: C-reactive protein (CRP) IVD, kit, spectrophotometry
JAS Diagnostics by Drew Scientific , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as C-reactive protein (CRP) IVD, kit, spectrophotometry.
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- Dimension CardioPhase high sensitivity CRP Flex reagent cartridge — Siemens Healthcare Diagnostics · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 HS CRP RGT KIT Pt No. ST645 — Carolina Liquid Chemistries Corp. · Class II
- HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT — BIOMERICA, INC. · Class II
- JAS Diagnostics — Drew Scientific , 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
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI 89e07af7-92d3-4608-a450-b496c3d061d0 35 fields · synced Jun 1, 2026