Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006247421

FEI Number

3006247421

Entity Name

DIAGNOSTICS FOR THE REAL WORLD, LTD.

City/State/Country

Morgan Hill, CA, US

Establishment Address

220 Vineyard Ct Ste 150, Morgan Hill, CA 95037, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

DIAGNOSTICS FOR THE REAL WORLD, LTD. (Owner Number: 9100726)

Owner / Operator Contact Address

220 Vineyard Court Ste 150, Morgan Hill, CA 95037, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SAMBA II SARS-CoV-2/FluA/FluB Test SAMBA II SARS-CoV-2/RSV Test FirstBurst Urine Collection Device SAMBA II HIV-1 Semi-Q Test SAMBA II HIV-1 Qual Whole Blood Test SAMBA HIV-1 Semi-Q Test SAMBA I HIV-1 Qual Whole Blood Test SAMBA II SARS-CoV-2 Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QOF	Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	Microbiology	Class 2	866.3981	2022-12-23
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2012-11-02
MTL	Monitor,Test,Hiv-1	Unknown	Class 3	N/A	2020-09-15
QQX	Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	Microbiology	Class 2	866.3981	2022-12-23

Official Correspondent

Lourdes Nadala

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DIAGNOSTICS FOR THE REAL WORLD, LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006247421. Last updated year: 2026. Please use registration number 3006247421 when referencing this establishment in official correspondence.