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Techlab, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000008412 FEI 1000123404

Techlab, Inc. is a medical device manufacturer based in the United States, with 92 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class I and II; EU Class B and IVD General) as of 14 Nov 2026.

Devices
92
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 57
  • FDA 510(k) 34
  • EUDAMED 27

A device listed in two registries counts in both.

Device classes
  • FDA Class I 64
  • FDA Class II 26
  • EU Class B 1
  • EU IVD General 1
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000008412
  • FDA FEI 1000123404
  • DUNS 614218634

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI
Authorised rep.
Emergo Europe B.V.NL

What Techlab, Inc. makes

TECHLAB, INC. manufactures in vitro diagnostic test kits for the detection of gastrointestinal pathogens and markers. Their product portfolio includes enzyme immunoassays, rapid immunochromatographic tests, and cell culture assays for identifying Clostridium difficile, Helicobacter pylori, Campylobacter species, Entamoeba histolytica, and other faecal parasites, as well as lactoferrin.

The company is based in the United States, and its devices are categorized as Class B, Class I, and Class II. These products are listed within the FDA 510(k) and UDI databases, as well as the EUDAMED registry.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue92

Newest first, rows 1-50 of 92

Search and filter all 92 devices
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  • Clostridium Perfringens Enterotoxin Test Ref T5006

    Active Regimes: CE IVDD Registry: EUDAMED Class:IVD General

  • H. Pylori Quik Chek T5050

    Active Regimes: 510(k) Registry: GUDID Class:I

  • E. Histolytica Ii T5017

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:II

  • C. Diff Quik Chek 30390

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:I

  • Tox A/B Quik Chek T5033

    Active Regimes: 510(k) Registry: GUDID Class:I

  • C. Difficile Tox A/B Ii T5015B

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:I

  • Giardia Ii PT5012

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Tri-Combo Parasite Screen T30408

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:II

  • H. Pylori Chek T5051B

    Active Regimes: 510(k) Registry: GUDID Class:I

  • E. Histolytica Ii 30404

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Campylobacter Chek T5052

    Active Regimes: 510(k) Registry: GUDID Class:I

  • C. Diff Quik Chek Complete T30550C

    Active Regimes: CE IVDR 510(k) Registry: EUDAMEDGUDID Class:I

  • Giardia/Cryptosporidium Chek T5031

    Active Regimes: 510(k) Registry: GUDID Class:II

  • C. Diff Chek - 60 T5025

    Active Regimes: 510(k) Registry: GUDID Class:I

  • H. Pylori Quik Chek 30925

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:I

  • C. Diff Quik Chek Complete 30525C

    Active Regimes: 510(k) Registry: GUDID Class:I

  • C. Diff Chek - 60 TL5025

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:I

  • Lactoferrin Scan 30351

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Lactoferrin Ez Vue T5018

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:I

  • Giardia Ii 30405

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Giardia/Cryptosporidium Quik Chek T30407

    Active Regimes: CE IVDR 510(k) Registry: EUDAMEDGUDID Class:II

  • C. Diff Chek - 60 30392B

    Active Regimes: 510(k) Registry: GUDID Class:I

  • C. Diff Quik Chek Complete 30550C

    Active Regimes: 510(k) Registry: GUDID Class:I

  • H. Pylori Chek 30996

    Active Regimes: 510(k) Registry: GUDID Class:I

  • QuickVue TLI Campylobacter Test 20344

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Cryptosporidium Ii PT5014

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Tox A/B Quik Chek 30394

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:I

  • Shiga Toxin Quik Chek T30625

    Active Regimes: CE IVDR 510(k) Registry: EUDAMEDGUDID Class:I

  • QuickVue TLI H. pylori Test 20343

    Active Regimes: 510(k) Registry: GUDID Class:I

  • C. Difficile Tox-B Test T5003

    Active Regimes: CE IVDD Registry: EUDAMEDGUDID Class:I

  • C. Difficile Tox A/B Ii 30397

    Active Regimes: 510(k) Registry: GUDID Class:I

  • C. Diff Chek - 60 T5025B

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:I

  • Leuko Ez Vue T5019

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Shiga Toxin Chek T30696

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:I

  • Asca-Chek T5016

    Listed Registry: GUDID Class:II

  • Campylobacter Chek T31096

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:I

  • C. Diff Quik Chek Complete T5038

    Active Regimes: CE IVDR 510(k) Registry: GUDID Class:I

  • C. Difficile Tox A/B Ii T5015

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:I

  • Campylobacter Quik Chek T31025

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:I

  • Giardia/Cryptosporidium Chek 30401

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:II

  • QuickVue TLI Lactoferrin Test 20345

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Campylobacter Quik Chek T5047

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Cryptosporidium Ii 30406

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:II

  • C. Difficile Tox A/B Ii 30397B

    Active Regimes: 510(k) Registry: GUDID Class:I

  • QuickVue TLI H. pylori Stool Antigen Test 20343

    Active Regimes: 510(k) Registry: GUDID Class:I

  • C. Difficile Toxin Antitoxin Kit T5000

    Active Regimes: 510(k) Registry: GUDID Class:I

  • C. Diff Chek - 60 30392

    Active Regimes: 510(k) Registry: GUDID Class:I

  • Lactoferrin Scan T5009

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:I

  • H. Pylori Chek T5051

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:I

  • E. Histolytica Quik Chek T30409

    Active Regimes: CE IVDD 510(k) Registry: EUDAMEDGUDID Class:II

Rows 1-50 of 92

Showing 1-50 of 92

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000008412
FDA FEI number
1000123404
DUNS number
614218634
EUDAMED status
Active
EUDAMED registered name
TECHLAB, Inc.
EUDAMED abbreviated name
TECHLAB
Registered address
2001, Kraft Drive, 24060, BLACKSBURG, United States
Phone
+1 540-953-1664
PRRC contact
Carlyn Ruble(public in EUDAMED)

Frequently asked questions

How many devices does TECHLAB, INC. have in the registry?

The registry currently lists 92 devices for TECHLAB, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list TECHLAB, INC.'s devices?

Among its 50 most recently registered devices, TECHLAB, INC. has devices listed in EUDAMED (24 devices) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do TECHLAB, INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for TECHLAB, INC.'s devices are Class I, Class II and IVD general. Each device page shows its own class and authorisation.

What are the newest devices from TECHLAB, INC. in the registry?

The most recently registered devices listed for TECHLAB, INC. include Clostridium Perfringens Enterotoxin Test, H. PYLORI QUIK CHEK T5050, E. HISTOLYTICA II T5017 and C. DIFF QUIK CHEK 30390.

Generated automatically from registry data and not verified by a human reviewer.