FDA.reportPublic FDA data

Fort Worth Diagnostics

Primary DI
00850051429738
Brand
Fort Worth Diagnostics
Company
Fort Worth Diagnostics, LLC
Model
EV004
Catalog number
EV004
Device description
Enterovirus Primer Set
Published
2025-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850051429738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051429738008500514297388500514297380850051429738

GMDN Terms#

Term, Definition table
TermDefinition
Assay development analyte-specific reagent IVDAn antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-20 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8174358511customerservice@fwdx.com

Regulatory Flags#

DUNS number
118977483
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850051429905Fort Worth DiagnosticsCTNGAIPCTNGAIP2026-04-06
00850051429912Fort Worth DiagnosticsTVMGAIPTVMGAIP2026-04-06
00850051429929Fort Worth DiagnosticsHPVAIPHPVAIP2026-04-06
00850051429936Fort Worth DiagnosticsVZV004VZV0042026-02-26
00850051429882Fort Worth DiagnosticsHSV1004HSV10042026-01-24
00850051429899Fort Worth DiagnosticsHSV2004HSV20042026-01-24
00850051429868Fort Worth DiagnosticsANA006ANA0062025-12-05
00850051429875Fort Worth DiagnosticsMIY006MIY0062025-12-05
00850051429745Fort Worth DiagnosticsPEV004PEV0042025-10-28
00850051429752Fort Worth DiagnosticsHHV6002HHV60022025-10-28
00850051429769Fort Worth DiagnosticsJCV001JCV0012025-10-28
00850051429714Fort Worth DiagnosticsMIY004MIY0042025-08-07
00850051429646Fort Worth DiagnosticsADV003ADV0032025-07-09
00850051429691Fort Worth DiagnosticsBAB003BAB0032025-06-23
00850051429707Fort Worth DiagnosticsBAB004BAB0042025-06-23
00850051429561Fort Worth DiagnosticsCAURPOSCAURPOS2025-06-20
00850051429578Fort Worth DiagnosticsTMNEGTMNEG2025-06-20
00850051429585Fort Worth DiagnosticsANAPOSANAPOS2025-06-20
00850051429592Fort Worth DiagnosticsBABPOSBABPOS2025-06-20
00850051429608Fort Worth DiagnosticsBORPOSBORPOS2025-06-20

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Primary DI, Brand, Company table
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08719327450956Anti-HbF FITCIQ Products B.V.MVU2023-01-26
08719327450963Anti-HbF R-PEIQ Products B.V.MVU2023-01-26
08719327450970Anti-HbF Dy-410IQ Products B.V.MVU2023-01-26
08719327450987anti-HbS PUREIQ Products B.V.MVU2023-01-26
08719327450994anti-HbS FITCIQ Products B.V.MVU2023-01-26
08719327451014CD163 PURE IQ Products B.V.MVU2023-01-26
08719327451021CD163 FITCIQ Products B.V.MVU2023-01-26
08719327451038CD163 R-PEIQ Products B.V.MVU2023-01-26
08719327451045CD163 BiotinIQ Products B.V.MVU2023-01-26
08719327451052CD64 PUREIQ Products B.V.MVU2023-01-26
08719327451069CD64 CyQIQ Products B.V.MVU2023-01-26
08719327451076CD64 FITCIQ Products B.V.MVU2023-01-26
08719327451083CD64 R-PEIQ Products B.V.MVU2023-01-26
08719327451090CD64 R-PEIQ Products B.V.MVU2023-01-26
08436548983413CD38-multi-epitope-FITCCYTOGNOS SLMVU2023-01-17
08436548984946CD45-APC-C750™CYTOGNOS SLMVU2023-01-17
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