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Texas Immunology, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
27

What Texas Immunology, Inc. makes

Texas Immunology, Inc. manufactures a range of diagnostic products including the FIRST SIGN, V-TREND QC TDM control serum, COUNT-10 TROL, and the V-TREND STREP A test. Their portfolio also includes the SERO/TEX LE, RF, and RPRL card tests, as well as the TARGET MYOGLOBIN, V-TREND TARGET IM, and V-TREND TARGET CRP tests, alongside DRUG CHECK and DRUG STOP testing kits.

The company is based in the United States and maintains a portfolio consisting of Class I, Class II, and U device classifications. These products are documented within the FDA 510(k) regulatory registry.

AI-generated from registry data, 28 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue27

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  • First Sign Ref K973208

    Class II
    Active 510(k) 510(k) II

  • V-Trend Qc Tdm Control Serum 1, 2, 3. Ref K862817

    Class I
    Active 510(k) 510(k) I

  • Count-10 Trol Ref K822540

    Class I
    Active 510(k) 510(k) I

  • V-Trend Strep A Test Ref K880483

    Class I
    Active 510(k) 510(k) I

  • Sero/Tex Le Test Ref K821385

    Class II
    Active 510(k) 510(k) II

  • Target Myoglobin Test Ref K963680

    Class II
    Active 510(k) 510(k) II

  • Drug Check Ref K980153

    Class II
    Active 510(k) 510(k) II

  • Drug Stop Ref K991465

    Unclassified
    Active 510(k) 510(k) —

  • V-Trend Target Im Test Ref K890041

    Class II
    Active 510(k) 510(k) II

  • V-Trend Target Crp Test Ref K892231

    Class II
    Active 510(k) 510(k) II

  • V-Trend Rprl Card Test Ref K875180

    Class II
    Active 510(k) 510(k) II

  • Sero/Tex Rf Test Ref K821319

    Class II
    Active 510(k) 510(k) II

  • Preg/Tex Pregnancy Test Ref K821387

    Class II
    Active 510(k) 510(k) II

  • Sero/Tex Mono Test Ref K821386

    Class II
    Active 510(k) 510(k) II

  • Sero/Tex Crp Test Ref K821388

    Class II
    Active 510(k) 510(k) II

  • V-Trend Beta-Hcg Dry-Spot Test Ref K875262

    Class II
    Active 510(k) 510(k) II

  • V-Trend Aso Plus Latex Test Ref K853857

    Class I
    Active 510(k) 510(k) I

  • V-Trend Beta-Hcg Test Ref K874638

    Class II
    Active 510(k) 510(k) II

  • V-Trend Im Dry-Spot Test Ref K880399

    Class II
    Active 510(k) 510(k) II

  • V-Trend Target Crp Test Ref K890423

    Class II
    Active 510(k) 510(k) II

  • Target Aso Test Ref K910073

    Class I
    Active 510(k) 510(k) I

  • Target Cardiac Troponin I Test Ref K972094

    Class II
    Active 510(k) 510(k) II

  • V-Trend Qc Urine Chemistry Controls Level, I & Ii Ref K861756

    Class I
    Active 510(k) 510(k) I

  • V-Trend Target Rf Test Ref K904105

    Class II
    Active 510(k) 510(k) II

  • V-Trend Kit Staph Latex Test Ref K855220

    Class I
    Active 510(k) 510(k) I

  • Target Microalbuminuria Test Ref K912246

    Class I
    Active 510(k) 510(k) I

  • Sero/Tex Red Cell Rf Test Ref K831597

    Class II
    Active 510(k) 510(k) II

Rows 1-27 of 27

Frequently asked questions

How many devices does Texas Immunology, Inc. have in the registry?

The registry currently lists 27 devices for Texas Immunology, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Texas Immunology, Inc.'s devices?

Among its 27 most recently registered devices, Texas Immunology, Inc. has devices listed in FDA 510(k) (27 devices).

What risk classes do Texas Immunology, Inc.'s devices fall under?

Among its 27 most recently registered devices, the classes recorded for Texas Immunology, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Texas Immunology, Inc. in the registry?

The most recently registered devices listed for Texas Immunology, Inc. include FIRST SIGN, V-TREND QC TDM CONTROL SERUM 1, 2, 3., COUNT-10 TROL and V-TREND STREP A TEST.

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