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
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