Identity
- Trade Name
- SAS CRP-Latex FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, rapid agglutination, clinical FDA UDI
- Device Name
- The SAS™ CRP-Latex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of C-Reactive Protein in human serum. FDA UDI
- Model / Reference
- 097100 FDA UDI
- Description
- The SAS™ CRP-Latex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of C-Reactive Protein in human serum. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00780311000080 FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, kit, rapid agglutination, clinical FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: C-reactive protein (CRP) IVD, kit, rapid agglutination, clinical
SAS CRP-Latex by Sa Scientific, Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as C-reactive protein (CRP) IVD, kit, rapid agglutination, clinical.
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Sa Scientific, Ltd
Sources (1)
- FDA UDI ff03fdd6-16b1-435a-af4f-257400a84bf7 33 fields · synced Jun 8, 2026