Identity
- Trade Name
- Pulse Scientific Inc. FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, reagent FDA UDI
- Model / Reference
- 10103 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628055726029 FDA UDI
- 510(k) Number
- K923768 FDA UDI
- FDA Product Code
- DCK FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, reagent 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: C-reactive protein (CRP) IVD, reagent
Pulse Scientific Inc. by Pulse Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as C-reactive protein (CRP) IVD, reagent.
- CRP — Randox Laboratories, Ltd. · Class II
- IMMUNEX CRP® — ALERE NORTH AMERICA, LLC · Class II
- K-ASSAY® hsCRP Reagent — KAMIYA BIOMEDICAL COMPANY, LLC · Class II
- Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- CRP Reagent Set — CLINICAL DIAGNOSTIC SOLUTIONS, INC. · Class II
- hsCRP — Randox Laboratories, Ltd. · Class II
- Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- CRP — Randox Laboratories, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pulse Scientific, Inc.
Sources (1)
- FDA UDI 3cdc7c60-b95a-4b7d-a9f2-ad47a101b01f 33 fields · synced May 31, 2026