FDA.reportPublic FDA data

Fort Worth Diagnostics

Primary DI
00810227730167
Brand
Fort Worth Diagnostics
Company
Fort Worth Diagnostics, LLC
Model
ANADIA
Catalog number
ANADIA
Device description
Anaplasma Direct Control 5E5 cp/mL
Published
2026-10-27
Public version status
New
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
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
00810227730167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810227730167008102277301678102277301670810227730167

GMDN Terms#

Term, Definition table
TermDefinition
Anaplasma phagocytophilum 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 Anaplasma phagocytophilum in a clinical specimen.

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
00810227730174Fort Worth DiagnosticsBABDIABABDIA2026-10-27
00810227730181Fort Worth DiagnosticsEHRDIAEHRDIA2026-10-27
00850051429943Fort Worth DiagnosticsSBNEGSBNEG2026-10-27
00850051429639Fort Worth DiagnosticsSBNEGSBNEG2025-06-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810227730174Fort Worth DiagnosticsFort Worth Diagnostics, LLCJJX2026-10-27
00810227730181Fort Worth DiagnosticsFort Worth Diagnostics, LLCJJX2026-10-27
00850011135921AccuTrakLgc Clinical Diagnostics, Inc.JJX2026-10-15
10758750035823VITROSORTHO CLINICAL DIAGNOSTICSJJX2026-08-26
00850011135884VALIDATELgc Clinical Diagnostics, Inc.JJX2026-08-25
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCJJX2026-08-13
00850075956777Refractrol SP NormalLgc Clinical Diagnostics, Inc.JJX2026-07-30
00850075956784Refractrol SP 9.0 HighLgc Clinical Diagnostics, Inc.JJX2026-07-30
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
05060169690899IDS High Sensitive Estradiol Control SetIMMUNODIAGNOSTIC SYSTEMS LIMITEDJJX2026-06-24
05060169691087IDS Estradiol Calibrator SetIMMUNODIAGNOSTIC SYSTEMS LIMITEDJJX2026-06-24
05060169697218IDS High Sensitive Estradiol Calibrator SetIMMUNODIAGNOSTIC SYSTEMS LIMITEDJJX2026-06-24
00195126001021NOVA Lite® IFA Hu (ANNA-1) Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00195126001038NOVA Lite® IFA Pancreatic Islet Cell Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00195126001045NOVA Lite® IFA Yo (PCA-1) Positive ControlINOVA DIAGNOSTICS, INC.JJX2026-06-09
00850011135877VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-05
00850011135891VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-02
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
30732671309403PipAMITY HOLDINGS, LLC DBA PIP DIABETES CAREJJX2026-04-16
10612479280509McKessonMCKESSON MEDICAL-SURGICAL INC.JJX2025-12-01
10840330706541TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-11-25
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