FDA.reportPublic FDA data

Tri-Tech Forensics, Inc.

Primary DI
00869373000235
Brand
Tri-Tech Forensics, Inc.
Company
TRI-TECH FORENSICS, INC.
Model
UC-1
Device description
Tri-Tech Forensics Urine Specimen Collection Kit
Published
2020-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
JXAKit, Screening, Urine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXAKit, Screening, UrineMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952246000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952246000TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KITTri-Tech, Inc.1995-06-20JXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869373000235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869373000235008693730002358693730002350869373000235

GMDN Terms#

Term, Definition table
TermDefinition
Urine specimen collection kit IVDA collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height2.5Inch
Length5Inch
Width3.75Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
105878292
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869373000211Tri-Tech Forensics, Inc.BA-2 DWI2020-02-25
00869373000259Tri-Tech Forensics, Inc.BA-0CO2020-02-25
00869373000204Tri-Tech Forensics, Inc.TUG102020-02-25
10869373000201Tri-Tech Forensics, Inc.TUG102020-02-25
00869373000228Tri-Tech Forensics, Inc.BU-3 DWI2020-02-25
00869373000242Tri-Tech Forensics, Inc.RE-1MS2020-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290006418111DIASLIDE URINE CULTURING DEVICESAVYON DIAGNOSTICS LTDJXA2026-05-04
07290013348531URISCREEN SAVYON DIAGNOSTICS LTDJXA2026-04-29
50885380070271CARDINAL HEALTHCardinal Health 200, LLCJXA2024-02-28
00860008737359Know Rapid STD TestMobiLab Medical Innovatives Inc.JXA2024-02-06
00860008737304MobiLab Standard Sexual Health Self Rapid TestMobiLab Medical Innovatives Inc.JXA2024-02-05
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00613647003626FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003633FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003640FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003657FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003664FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003701FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
00613647003718FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
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20613647003637FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003644FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003651FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
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00613647003695FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003705FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
20613647003712FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.JXA2022-12-07
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03573026600402CHROMID® CPS® Elite Agar (CPSO)BIOMERIEUX SAJXA2020-05-19
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