FDA Registration Active 🇺🇸 United States

EXACT DIAGNOSTICS

Reg #: 3011926203 · FEI: 3011926203 · Expires 2026
Products
2
Proprietary Names
159
Establishment Types
1
Classifications
2

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Registration Details

Registration Name
EXACT DIAGNOSTICS
Registration Number
3011926203
FEI Number
3011926203
Status
Active
Expiry Year
2026
Initial Importer
No
Address
100 South Jones Street Suite #100
City
Fort Worth
State
TX
ZIP
76104
Country
US

Owner / Operator

Firm Name
Bio-Rad Laboratories, Inc.
Operator Number
9929003
Address
4000 Alfred Nobel Drive, --
City
Hercules
State
CA
Postal Code
94547
Country
US
Correspondent
Elizabeth Platt

Products

Device Name Product Code
Multi-Analyte Controls Unassayed OHQ
Calibrator, Secondary JIT

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]

Establishment Types

Manufacture Medical Device