FDA.reportPublic FDA data

Histoplex

Primary DI
10840165401062
Brand
Histoplex
Company
Pretium Canada Packaging ULC
Model
H602-FL
Device description
Specimen Container, 60 ml, Yellow Cap, 10% Buffered Formalin Label, Non-Sterile.
Published
2025-03-04
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
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840165401072PackageGS15In Commercial Distribution
10840165401062PrimaryGS10
00840165401065Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840165401072008401654010728401654010720840165401072
1084016540106210840165401062
00840165401065008401654010658401654010650840165401065

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
246665038
Device count
100
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840165401560Pinworm CollectorV302-PIN2025-10-07
10840165401185LeakbusterB602-1YN2025-04-29
10840165401406LeakbusterB602-1YNL2025-04-29
00840165400860StarplexV102-CA2025-04-29
10840165400867StarplexV102-CA2025-04-29
00840165401195LeakbusterB602-1YN2025-04-29
00840165401416LeakbusterB602-1YNL2025-04-29
10840165400966Starplex V302-F2025-03-04
00840165400976Starplex V302-F2025-03-04
00840165401072HistoplexH602-FL2025-03-04
00840165400266Starswab II Bacteriology Culture Collection and Transport SystemSP132-W2025-02-21
00840165400280Starswab II Bacteriology Culture Collection and Transport SystemSP132-FL2025-02-21
00840165400303Starswab II Bacteriology Culture Collection and Transport SystemSP130L2025-02-21
00840165400327Starswab II Bacteriology Culture Collection and Transport SystemSP130L-D2025-02-21
00840165400341Starswab II Bacteriology Culture Collection and Transport SystemSP130L-W2025-02-21
00840165400365Starswab Dry SwabS092025-02-21
00840165400389Starswab Dry SwabS09D2025-02-21
00840165400402Starswab Anaerobic Transport SystemS120-02025-02-21
00840165400426Starswab Anaerobic Transport SystemS120-D2025-02-21
00840165400440Starswab Anaerobic Transport SystemS120-52025-02-21

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Primary DI, Brand, Company table
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00860013988050Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988067Advance Dx Blood Collection Card: Single strip cards - no lines on the frontADVANCE DX, INC.NNK2026-03-03
00860013988074Advance Dx Blood Collection Card: Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00860013988098Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
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