Consulting Wallah › Device Explorer › IVD & laboratory › C-reactive protein (CRP) IVD, kit, nephelometry/tu
Device Explorer · FDA GUDID · GMDN 53705

C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen, using a nephelometry/turbidimetry method [includes high-sensitivity CRP (hsCRP) ty

US‑registered devices63in commercial distribution
Companies13labelers on GUDID
Single‑use48%of device records
Sterile0%labelled sterile
Prescription68%Rx‑only share
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Share of device records

Roche Diagnostics Gmbh2032%
Beckman Coulter, Inc.813%
Siemens Healthcare Diagnostics Products Gmbh711%
Siemens Healthcare Diagnostics Inc.610%
Abbott Laboratories610%
Horiba Instruments Incorporated58%
Horiba Abx Sas46%
Diazyme Laboratories, Inc.23%

Top labelers

CompanyDevicesShare
Roche Diagnostics Gmbh2032%
Beckman Coulter, Inc.813%
Siemens Healthcare Diagnostics Products Gmbh711%
Siemens Healthcare Diagnostics Inc.610%
Abbott Laboratories610%
Horiba Instruments Incorporated58%
Horiba Abx Sas46%
Diazyme Laboratories, Inc.23%
Aidian Oy12%
The Binding Site Group Limited12%
Diagnostic Automation, Inc.12%
Drew Scientific, Inc.12%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Tina-quant Cardiac high sensitivity CRP IIITina-quant C-Reactive Protein IVCardiac C-Reactive Protein (Latex) High SensitivC-Reactive Protein Gen.3QuikRead go® CRPOptilite High Sensitivity C-Reactive Protein KitTina-quant CReactive Protein IVCardiac CReactive Protein Latex High SensitiveCreactive protein latex)CReactive Protein Gen3Tinaquant CReactive Protein Gen3CReactive Protein Latex)Tinaquant Cardiac Creactive Protein Latex High SYumizen C1200 CRPABX PENTRA CRP CPABX CRP REA

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
DCNSYSTEM, TEST, C-REACTIVE PROTEIN21
NQDCARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL16
DCKC-Reactive Protein, Antigen, Antiserum, And Control14
DCKC-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL10
DCNSystem, Test, C-Reactive Protein5
NQDCardiac C-Reactive Protein, Antigen, Antiserum, And Control3

GMDN & GCC registration

  • GMDN code 53705 · non‑implantable
  • Single‑use 48% · sterile 0% · Rx‑only 68% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many c-reactive protein (crp) ivd, kit, nephelometry/turbidimetry products are registered in the US?

63 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetry", from 13 companies. The largest labeler is Roche Diagnostics Gmbh with 32% of records.

Which FDA product codes apply?

DCN (SYSTEM, TEST, C-REACTIVE PROTEIN), NQD (CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL), DCK (C-Reactive Protein, Antigen, Antiserum, And Control), DCK (C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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