FDA.reportPublic FDA data

Diagnostic BioSystems

Primary DI
00846405023431
Brand
Diagnostic BioSystems
Company
Diagnostic Biosystems, Inc.
Model
KT038
Device description
Papanicolaou (PAP), 100 tests
Published
2026-06-09
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
true

Product Codes#

Code, Name table
CodeName
NJTImmunohistochemistry Reagents And Kits

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJTImmunohistochemistry Reagents And KitsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846405023431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846405023431008464050234318464050234310846405023431

GMDN Terms#

Term, Definition table
TermDefinition
Endocervical specimen cytological examination kit IVDA collection of noninvasive in vitro diagnostic devices intended to be used in the clinical laboratory for the preparation, processing, and microscopic examination of an endocervical cytological specimen previously collected from a patient, typically as part of a woman's regular pelvic examination and cervical cancer screening. It may be referred to as Papanicolaou (Pap) smear test and typically consists of specimen suspension homogenization reagents and preservatives, cytological centrifuge funnels, fixative/stain solutions, and microscopy slides. This is a single-use device.

Regulatory Flags#

DUNS number
926549064
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00846405000166Diagnostic BioSystemsMob5692026-06-09
00846405000173Diagnostic BioSystemsMob569-052026-06-09
00846405000180Diagnostic BioSystemsMob569-012026-06-09
00846405000678Diagnostic BioSystemsMob0802026-06-09
00846405000685Diagnostic BioSystemsMob080-052026-06-09
00846405000692Diagnostic BioSystemsMob080-012026-06-09
00846405000760Diagnostic BioSystemsMob0592026-06-09
00846405000777Diagnostic BioSystemsMob059-052026-06-09
00846405000784Diagnostic BioSystemsMob059-012026-06-09
00846405000791Diagnostic BioSystemsMob0542026-06-09
00846405000807Diagnostic BioSystemsMob054-052026-06-09
00846405000814Diagnostic BioSystemsMob054-012026-06-09
00846405001156Diagnostic BioSystemsMob2782026-06-09
00846405001163Diagnostic BioSystemsMob278-052026-06-09
00846405001170Diagnostic BioSystemsMob278-012026-06-09
00846405001187Diagnostic BioSystemsMob5532026-06-09
00846405001194Diagnostic BioSystemsMob553-012026-06-09
00846405001200Diagnostic BioSystemsMob553-052026-06-09
00846405001309Diagnostic BioSystemsMob2912026-06-09
00846405001316Diagnostic BioSystemsMob291-052026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846405000166Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000173Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000180Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000678Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000685Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000692Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000760Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000777Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000784Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000791Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000807Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405000814Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001156Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001163Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001170Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001187Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001194Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001200Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001309Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001316Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001323Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001453Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001460Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001477Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001811Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001828Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001835Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001842Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001859Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09
00846405001866Diagnostic BioSystemsDiagnostic Biosystems, Inc.NJT2026-06-09