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Teco Diagnostics C-Reactive Protein (CRP) Reagent Set

FDA UDI

Class II (US FDA UDI)

by Teco Diagnostics

Identity

Trade Name
Teco Diagnostics C-Reactive Protein (CRP) Reagent Set FDA UDI
Generic Name
C-reactive protein (CRP) IVD, kit, rapid agglutination, clinical FDA UDI
Device Name
Teco Diagnostics C-Reactive Protein (CRP) Reagent Set is used for the qualitative and semi-quantitative measurement of C-reactive protein (CRP) in human serum. FDA UDI
Model / Reference
CRP-100 FDA UDI
Description
Teco Diagnostics C-Reactive Protein (CRP) Reagent Set is used for the qualitative and semi-quantitative measurement of C-reactive protein (CRP) in human serum. FDA UDI

Identifiers

Catalog Number
CRP-100 FDA UDI
Primary DI / UDI-DI
10673486002430 FDA UDI
510(k) Number
K962019 FDA UDI
FDA Product Code
DCK FDA UDI
GMDN Term
C-reactive protein (CRP) IVD, kit, rapid agglutination, clinical 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: C-reactive protein (CRP) IVD, kit, rapid agglutination, clinical

Teco Diagnostics C-Reactive Protein (CRP) Reagent Set by Teco Diagnostics — Class II — 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

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Manufacturer

Manufacturer
Teco Diagnostics

Sources (1)

  • FDA UDI b57c327e-bfe6-4e91-aee6-46bd5b8226ea 37 fields · synced May 30, 2026