FDA.reportPublic FDA data

Fort Worth Diagnostics

Primary DI
00850051429639
Brand
Fort Worth Diagnostics
Company
Fort Worth Diagnostics, LLC
Model
SBNEG
Catalog number
SBNEG
Device description
Stabilized Blood Dilution Matrix
Published
2025-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHQMulti-Analyte Controls Unassayed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHQMulti-Analyte Controls UnassayedClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850051429639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051429639008500514296398500514296390850051429639

GMDN Terms#

Term, Definition table
TermDefinition
Molecular grade buffered sample diluent IVDA molecular grade buffered solution intended to be used as a diluent for a clinical specimen, reagent and/or other substances used prior to, or during an assay using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
8174358511customerservice@fwdx.com

Regulatory Flags#

DUNS number
118977483
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810227730211Fort Worth DiagnosticsMIY003MIY0032026-07-24
00850051429820Fort Worth DiagnosticsANA001ANA0012026-07-24
00850051429837Fort Worth DiagnosticsBAB001BAB0012026-07-24
00850051429844Fort Worth DiagnosticsEHR001EHR0012026-07-24
00850051429851Fort Worth DiagnosticsMIY001MIY0012026-07-24
00810227730006Fort Worth DiagnosticsLPNE002LPNE0022026-07-22
00810227730013Fort Worth DiagnosticsBGLO002BGLO0022026-07-22
00810227730020Fort Worth DiagnosticsLSPP003LSPP0032026-07-22
00810227730037Fort Worth DiagnosticsLPNE003LPNE0032026-07-22
00850051429967Fort Worth DiagnosticsLSPP001LSPP0012026-07-22
00850051429974Fort Worth DiagnosticsLPNE001LPNE0012026-07-22
00850051429981Fort Worth DiagnosticsBGLO001BGLO0012026-07-22
00850051429998Fort Worth DiagnosticsLSPP002LSPP0022026-07-22
00810227730044Fort Worth DiagnosticsPJP001PJP0012026-07-21
00810227730051Fort Worth DiagnosticsPJP002PJP0022026-07-21
00810227730068Fort Worth DiagnosticsPJP003PJP0032026-07-21
00810227730136Fort Worth DiagnosticsCOCC002COCC0022026-07-21
00810227730143Fort Worth DiagnosticsCIMM002CIMM0022026-07-21
00810227730150Fort Worth DiagnosticsCPOS002CPOS0022026-07-21
00810227730228Fort Worth DiagnosticsRSV001RSV0012026-07-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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01220000260603NATtrol™ZEPTOMETRIX CORPORATIONOHQ2026-06-04
01220000260610NATtrol™ZEPTOMETRIX CORPORATIONOHQ2026-06-04
05391523442800Multichem AE TECHNO-PATH MANUFACTURING LIMITEDOHQ2026-05-11
05391523442817Multichem AE TECHNO-PATH MANUFACTURING LIMITEDOHQ2026-05-11
05391523442824Multichem AE TECHNO-PATH MANUFACTURING LIMITEDOHQ2026-05-11
00850051429905Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2026-04-06
00850051429912Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2026-04-06
00850051429929Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2026-04-06
05056850400052Mimix™ Geni™ OncoMix 1 DNA/RNA FFPE Reference StandardREVVITY DISCOVERY LIMITEDOHQ2026-03-27
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01220000260641NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2026-03-25
70845357044432QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2026-02-10
00852720008244Birlinn™ CoV2-Flu-RSV Control Panel M509MmqciOHQ2025-12-04
01220000260634NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-12-01
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01220000260467NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-09-10
70845357044340QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
70845357044395QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
05056850400038Mimix™ Quantitative Multiplex FFPE reference standardREVVITY DISCOVERY LIMITEDOHQ2025-08-15
80845357044422Helix Elite Molecular StandardsMICROBIOLOGICS INC.OHQ2025-08-14
01220000260627NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-08-06
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08718734962946CueSee® BGEMEurotrol B.V.OHQ2025-07-25
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08718734962960CueSee® BGEMEurotrol B.V.OHQ2025-07-25
01220000260481NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-07-25
08718734962991CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963004CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963011CueSee® BGEMEurotrol B.V.OHQ2025-07-25