FDA.reportPublic FDA data

Fort Worth Diagnostics

Primary DI
00850051429936
Brand
Fort Worth Diagnostics
Company
Fort Worth Diagnostics, LLC
Model
VZV004
Catalog number
VZV004
Device description
VZV Primer Set
Published
2026-02-26
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
00850051429936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051429936008500514299368500514299360850051429936

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

Sterilization Methods#

Method table
Method

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
00850051429882Fort Worth DiagnosticsHSV1004HSV10042026-01-24
00850051429899Fort Worth DiagnosticsHSV2004HSV20042026-01-24
00850051429868Fort Worth DiagnosticsANA006ANA0062025-12-05
00850051429875Fort Worth DiagnosticsMIY006MIY0062025-12-05
00850051429738Fort Worth DiagnosticsEV004EV0042025-10-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055844935761CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06
05055844935778CytoCell myProbesCYTOCELL LIMITEDMVU2026-06-06
00810034704085FITC anti-human Granzyme BBIOLEGEND, INC.MVU2026-06-05
00810034704146PE/Cyanine7 anti-human Granzyme BBIOLEGEND, INC.MVU2026-06-05
00810034704160APC anti-human CD64BIOLEGEND, INC.MVU2026-06-05
00810034704177FITC anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034704191PE/Cyanine7 anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034704214APC anti-human CD31BIOLEGEND, INC.MVU2026-06-05
00810034704245APC anti-human CD274BIOLEGEND, INC.MVU2026-06-05
00810034704290APC/Fire™ 750 anti-human CD69BIOLEGEND, INC.MVU2026-06-05
00810034702951PerCP/Cyanine5.5 anti-human Beta2-microglobulinBIOLEGEND, INC.MVU2026-06-01
00810034704061PE/Dazzle™ 594 anti-human CD22BIOLEGEND, INC.MVU2026-06-01
00810034704092FITC anti-human CD35BIOLEGEND, INC.MVU2026-06-01
00810034704108PE/Cyanine7 anti-human CD22BIOLEGEND, INC.MVU2026-06-01
00810034704139PE/Cyanine7 anti-human CD300eBIOLEGEND, INC.MVU2026-06-01
08595715450544CyFlow™ CD200 PE-Cy7EXBIO Praha, a.s.MVU2025-10-01
08719327450949Anti-HbF PUREIQ Products B.V.MVU2023-01-26
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