FDA.reportPublic FDA data

Fort Worth Diagnostics

Primary DI
00850051429615
Brand
Fort Worth Diagnostics
Company
Fort Worth Diagnostics, LLC
Model
EHRPOS
Catalog number
EHRPOS
Device description
Ehrlichia Control 5E4 cp/mL
Published
2025-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850051429615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051429615008500514296158500514296150850051429615

GMDN Terms#

Term, Definition table
TermDefinition
Ehrlichia chaffeensis nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from the rickettsial bacteria Ehrlichia chaffeensis in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118977483
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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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00850075956807Refractrol SP HighLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075957286Refractrol SP LowLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075956791Refractrol SP 6.0 LowLgc Clinical Diagnostics, Inc.JJX2026-07-28
10758750035847VITROSORTHO CLINICAL DIAGNOSTICSJJX2026-07-21
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05060169697218IDS High Sensitive Estradiol Calibrator SetIMMUNODIAGNOSTIC SYSTEMS LIMITEDJJX2026-06-24
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00850011135877VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-05
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00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015404TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00021292015411TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
00015482510060Assure® Control - Control Solution Level 2 & Level 3Arkray USA, Inc.JJX2025-09-26
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