EXACT DIAGNOSTICS

FDA Device Registration & Listing · Fort Worth, TX, US · Registration 3011926203

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011926203
FEI Number
3011926203
Entity Name
EXACT DIAGNOSTICS
City/State/Country
Fort Worth, TX, US
Establishment Address
100 South Jones Street Suite #100, Fort Worth, TX 76104, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Bio-Rad Laboratories, Inc. (Owner Number: 9929003)
Owner / Operator Contact Address
4000 Alfred Nobel Drive, --, Hercules, CA 94547, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

VIROTROL MuMZ Liquichek Unassayed Chemistry VIROTROL HBeAg VIROTROL EBV VIROCLEAR EBV VIROCLEAR ToRCH VIROTROL Syphilis LR-A VIROTROL Lyme Liquid Unassayed Multiqual VIROCLEAR MuMZ VIROTROL HAV-IgM Liquichek Netherlands Unassayed Chemistry Plus Control VIROTROL RPR Panel VIROTROL PLUS R PyloriTrol Lyphochek Unassayed Chemistry VIROTROL HIV-1 gO Liquichek Sedimentation Rate Control VIROTROL ToRCH-M [00117A, 00117B] EDX SARS-CoV-2, Flu, RSV Negative Run Control [COVFLUNEG] EDX HSV-2 Verification Panel [HSV2P100] EDX HSV-1 Low Run Control [HSV1L101] EDX HPV Genotype 16 Control [HPV16C] EDX Parvovirus B19 Verification Panel [B19P100] EDX HSV-1 High Run Control [HSV1H102] EDX SARS-CoV-2 Negative Run Control [COV000CE] EDX Respiratory Negative Run Control [RPNEG] EDX HSV-1 Verification Panel [HSV1P100] HCV 1E6 IU/mL Precision [HCVH202] EDX VZV High Run Control [VZVH102] EDX CMV Verification Panel 1mL [CMVP100] EDX HCV High Run Control [HCVH102] EDX Adenovirus High Run Control [ADVH102] EDX HHV-6B Verification Panel [HV6BP100] BKV Verification Panel 1.4 IU/mL [BKVP200] EDX HIV-1 High Run Control [HIVH102] HIV-1 1E3 cp/mL Precision [HIVL201] EDX JCV High Run Control [JCVH102] EDX HPV Genotype 68 Control [HPV68C] EDX EBV Low Run Control [EBVL101] EDX HBV Verification Panel 1mL [HBVP100] EDX HPV Negative Control [HPVNEG] EDX HBV Verification Panel 1.4mL [HBVP200] EDX CMV Verification Panel 1.4mL [CMVP200] EDX BKV Verification Panel [BKVP100] CMV LOD [CMVLOD] HIV-1 LOD [HIVLOD] EDX HBV High Run Control [HBVH102] EDX Ehrlichia Run Control [ERLRC] EDX ZKV High Run Control [ZKVH102] EDX BKV Low Run Control [BKVL101] EDX Respiratory Run Control [RPRC] BKV 1E3 IU/mL Precision [BKVL201] EDX HHV-6A Verification Panel [HV6AP100] EDX Anaplasma Run Control [ANARC] EDX MRSA Verification Bundle [MRSAP200] EDX HSV-2 Low Run Control [HSV2L101] EDX HIV-1 Analytical Measurement Range Panel [HIVAMR] EDX ZKV Low Run Control [ZKVL101] EBV LOD [EBVLOD] EDX Enterovirus Run Control [EVRC] EDX Borrelia Run Control [BORRC] EDX VZV Verification Panel [VZVP100] EDX Negative Run Control [NEG000] EDX Babesia Run Control [BABRC] CMV 5E5 IU/mL Precision [CMVH202] EDX HBV Low Run Control [HBVL101] EDX CT/NG Run Control [CTNGRC] HIV-1 1E5 cp/mL Precision [HIVH202] EDX SARS-CoV-2, Flu, RSV Positive Run Control [COVFLU] EDX CMV Low Run Control [CMVL101] EDX HIV-1 Verification Panel 1mL [HIVP100] EDX HCV Verification Panel 1.4mL [HCVP200] EBV Verification Panel 1.4 IU/mL [EBVP200] EDX C. difficile Verification Bundle [CDFP200] EDX HBV Analytical Measurement Range Panel [HBVAMR] EDX Parvovirus B19 Low Run Control [B19L101] EDX CMV High Run Control [CMVH102] EDX SARS-CoV-2 Positive Run Control [COV019CE] EDX HPV Genotype 18 Control [HPV18C] BKV 5E5 IU/mL Precision [BKVH202] EDX CT/NG Verification Bundle [CTNGP200] EDX EBV Verification Panel [EBVP100] EDX HPV Verification Panel [HPVP200] EDX HCV Low Run Control [HCVL101] EDX VZV Low Run Control [VZVL101] EDX Adenovirus Low Run Control [ADVL101] EDX EBV High Run Control [EBVH102] EDX JCV Verification Panel [JCVP100] EDX HHV-6 High Run Control [HV6H102] EDX Bulk Negative [NEG050] EDX Respiratory Positive Run Control [RPPOS] HCV 1E3 IU/mL Precision [HCVL201] EBV 5E5 IU/mL Precision [EBVH202] EDX HHV-6 Low Run Control [HV6L101] EDX TV/MG Verification Bundle [TVMGP200] HBV LOD [HBVLOD] EDX HIV-1 Low Run Control [HIVL101] HCV LOD [ HCVLOD] EDX Parvovirus B19 High Run Control [B19H102] EDX BKV High Run Control [BKVH102] HBV 1E3 IU/mL Precision [HBVL201] EDX HCV Verification Panel 1mL [HCVP100] EDX Adenovirus Verification Panel [ADVP100] EDX HIV-1 Verification Panel 1.4mL [HIVP200] HBV 1E6 IU/mL Precision [HBVH202] EDX Bartonella Run Control [BRTRC] CMV 1E3 IU/mL Precision [CMVL201] EDX JCV Low Run Control [JCVL101] EBV 1E3 IU/mL Precision [EBVL201] EDX HSV-2 High Run Control [HSV2H102] EDX HCV Analytical Measurement Range Panel [HCVAMR] BKV LOD [BKVLOD] EDX ZKV Verification Panel [ZKVP100] EDX BKV Urine LOD [BKVULOD] EDX CT/NG Positive Run Control [CTNGPOS] EDX HAI Run Control [NEGHAI] EDX Synthetic Negative Run Control [NEGSYN] EDX Bulk CSF Negative [12019432] EDX GBS Positive Run Control [12020069] EDX STI Negative Run Control [NEGSTI] EDX GBS Negative Run Control [12020068] Liquichek ToRCH Plus Control, Negative Liquichek ToRCH Plus Control, Positive Unassayed VIROTROL Chagas Exact Diagnostics JCV Verification Panel [JCVP100] Exact Diagnostics HBV Verification Panel 1.4 mL [HBVP200] Exact Diagnostics HIV-1 Verification Panel 1.4 mL [HIVP200] Exact Diagnostics HSV-2 Verification Panel [HSV2P100] Exact Diagnostics HHV-6A Verification Panel [HV6AP100] Exact Diagnostics CMV 5E5 IU/mL Precision [CMVH201] Exact Diagnostics Zika Verification Panel [ZKVP100] Exact Diagnostics CT/NG Verification Panel [CTNGP200] Exact Diagnostics Parvovirus B19 Verification Panel [B19P100] Exact Diagnostics HBV Verification Panel [HBVP100] Exact Diagnostics VZV Verification Panel [VZVP100] Exact Diagnostics HCV 1E3 IU/mL Precision [HCVL201] Exact Diagnostics HCV Verification Panel 1.4 mL [HCVP200] Exact Diagnostics HHV-6B Verification Panel [HV6BP100] Exact Diagnostics HBV 1E3 IU/mL Precision [HBVL201] Exact Diagnostics TV/MG Verification Panel [TVMGP200] Exact Diagnostics HSV-1 Verification Panel [HSV1P100] Exact Diagnostics HCV LOD [HCVLOD] Exact Diagnostics CMV Verification Panel [CMVP100] Exact Diagnostics CMV LOD [CMVLOD] Exact Diagnostics CMV 1E3 IU/mL Precision [CMVL201] Exact Diagnostics HIV-1 1E3 cp/mL Precision [HIVL201] Exact Diagnostics HIV-1 1E5 cp/mL Precision [HIVH202] Exact Diagnostics EBV Verification Panel [EBVP100] Exact Diagnostics HCV 1E6 IU/mL Precision [HCVH202] Exact Diagnostics BKV Verification Panel [BKVP100] Exact Diagnostics HBV 1E6 IU/mL Precision [HBVH202] Exact Diagnostics C. difficile Verification Panel [CDFP200] Exact Diagnostics HCV Verification Panel [HCVP100] Exact Diagnostics HBV LOD [HBVLOD] Exact Diagnostics HIV-1 Verification Panel [HIVP100] Exact Diagnostics CMV Verification Panel 1.4 mL [CMVP200] Exact Diagnostics HIV-1 LOD [HIVLOD] Exact Diagnositics Adenovirus Verification Panel [ADVP100]

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OHQ Multi-Analyte Controls Unassayed Clinical Chemistry Class 1 862.1660 2008-04-11
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2020-08-03

Official Correspondent

Elizabeth Platt

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bio-Rad Laboratories, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3032023483 Bio-Rad Laboratories (S) Pte Ltd Singapore South West, SG
3006421415 Bio-Rad Laboratories (Singapore) Pte. Ltd. Singapore Central Singapore, SG
2016706 Bio-Rad Laboratories Inc. IRVINE, CA, US
3010127294 Bio-Rad Laboratories Inc. Irvine, CA, US
2915274 Bio-Rad Laboratories, Inc. Hercules, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K935876 Bio-Rad Laboratories, Inc. ACCESS SPECIFIC IGE ASSAY 1994-03-11
K882259 Diagnostic Chemicals, Ltd. (Usa) DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023 1988-07-21
K060322 Cliniqa Corporation CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED 2006-03-21
K081789 Siemens Healthcare Diagnostics, Inc. DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR 2008-09-10
K103836 Siemens Healthcare Diagnostics, Inc. ENZYME II CALIBRATOR 2011-02-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0017-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A1c in human whole blood. IVD Contents: 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer 2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer 3. Wash/Diluent 1 x 1600 mL Deionized water 4. Analytical cartridge - 1 cation exchange cartridge 5. Floppy Diskette 1-program parameters 6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water. 7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative. 8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid 9 Thermal paper - 1 roll 10. Instruction manual Made in United States Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0018-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0019-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0020-2012 Bio-Rad Laboratories, Inc. 2
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 4 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 2 vial each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0021-2012 Bio-Rad Laboratories, Inc. 2
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 5 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 3 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011926203. Last updated year: 2026. Please use registration number 3011926203 when referencing this establishment in official correspondence.
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