FDA.reportPublic FDA data

Histoplex

Primary DI
10840165500185
Brand
Histoplex
Company
Starplex Scientific Corp.
Model
H902-FL
Device description
Specimen Container, 90 ml, Yellow Cap, Affixed 10% Buffered Formalin Label, Non-Sterile.
Published
2025-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NNIContainer, Specimen, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840165500195PackageGS14In Commercial Distribution
10840165500185PrimaryGS10
00840165500188Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840165500195008401655001958401655001950840165500195
1084016550018510840165500185
00840165500188008401655001888401655001880840165500188

GMDN Terms#

Term, Definition table
TermDefinition
General tissue specimen container IVD, no additiveA covered receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) collected from any body part for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Regulatory Flags#

DUNS number
859771235
Device count
100
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840165500727StarCLICK 100B1002-OCCTS2025-10-10
10840165500741StarCLICK 100B1002-YCCNLTS2025-10-10
10840165500765StarCLICK 100B1002-YCCTS2025-10-10
10840165500802LeakbusterB1202-1YNL2025-10-10
10840165500567LeakbusterWB902-1BNL2025-10-07
10840165500581LeakbusterWB902-1ONTSTAB2025-10-07
10840165500604LeakbusterWB902-1WNL2025-10-07
10840165500628LeakbusterWB902-1WTS2025-10-07
10840165500642LeakbusterB1202-1ONL2025-10-07
10840165500666LeakbusterB1202-1OTS2025-10-07
10840165500680LeakbusterB902-1YNL2025-10-07
10840165500703LeakbusterB902-1WNL2025-10-07
00840165500553Starplex Specimen ContainerWB902-SO-OR2025-10-07
10840165500208HistoplexH1202-FL2025-05-30
00840165500218HistoplexH1202-FL2025-05-30
10840165500048LeakbusterWB902-1O2025-05-28
10840165500062StarCLICK 100B1002-OCC2025-05-28
10840165500086StarCLICK 100B1002-YCC2025-05-28
10840165500109LeakbusterB902-1YN2025-05-28
10840165500123LeakbusterWB902-1YN2025-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800075627520OSUNG MNDOSUNG MND Co., Ltd.NNI2025-11-03
10840165500741StarCLICK 100Starplex Scientific Corp.NNI2025-10-10
10840165500765StarCLICK 100Starplex Scientific Corp.NNI2025-10-10
10840165500802LeakbusterStarplex Scientific Corp.NNI2025-10-10
10840165500567LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500581LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500604LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500628LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500642LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500680LeakbusterStarplex Scientific Corp.NNI2025-10-07
10840165500703LeakbusterStarplex Scientific Corp.NNI2025-10-07
10827989007731Health Care Logistics, Inc®Health Care Logistics, Inc.NNI2025-09-16
10840165500208HistoplexStarplex Scientific Corp.NNI2025-05-30
10840165500086StarCLICK 100Starplex Scientific Corp.NNI2025-05-28
10840165500109LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500123LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500147LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500161LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500406LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165500420LeakbusterStarplex Scientific Corp.NNI2025-05-28
10840165401185LeakbusterPretium Canada Packaging ULCNNI2025-04-29
10840165401406LeakbusterPretium Canada Packaging ULCNNI2025-04-29
00616784802138LabChoice Specimen Bags, Clear, 8" x 10"(20.3 cm x 25.4 cm) , 1.8 milDynarex CorporationNNI2025-04-07
00840117333420LabChoice Specimen Bags with Pouch, 4" x 6" (10.2 cm x 15.2 cm), 1.8 milDynarex CorporationNNI2025-04-07
19120126131452VACUETTEGreiner Bio-One GmbHNNI2025-04-02
00616784802039LabChoice Specimen Bags, 6" x 9" (15.2 cm x 22.9 cm), 1.8 mil, Non-SterileDynarex CorporationNNI2025-03-28
00840117333413LabChoice Specimen Bags, 12" x 15" (30.5 cm x 38.1 cm), 1.8 milDynarex CorporationNNI2025-03-28
10860009784892Ditek Urine Collection CupMedzah IndustriesNNI2025-03-06
10840165400966Starplex Pretium Canada Packaging ULCNNI2025-03-04
30197344020762MEDLINEMEDLINE INDUSTRIES, INC.NNI2024-11-22