FDA.reportPublic FDA data

Tri-Tech Forensics, Inc.

Primary DI
00869373000242
Brand
Tri-Tech Forensics, Inc.
Company
TRI-TECH FORENSICS, INC.
Model
RE-1MS
Device description
Tri-Tech Forensics Custom Sexual Assault 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
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922343000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922343000TRI-TECH INC. CUSTOM SEXUAL ASSAULT KITTri-Tech, Inc.1994-02-17JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869373000242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869373000242008693730002428693730002420869373000242

GMDN Terms#

Term, Definition table
TermDefinition
Victim sexual-assault forensic evidence kitA collection of sterile devices and materials designed to be used during a forensic investigation to facilitate the acquisition of sexual-assault evidence from an alleged live victim. It typically includes devices to make and mail vaginal, rectal, and oral swabs and smears (e.g., cotton swabs with microscope slides and slide mailers); devices to collect samples of blood, saliva, and pubic hairs (e.g., blood collection tubes, filter paper disk, comb); containers (e.g., envelopes, bags) to collect pulled head/pubic hair, clothing, debris, and foreign material; and sometimes anatomical drawings and forms for medical history and consent. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height2.375Inch
Length10.25Inch
Width6.75Inch

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
00869373000235Tri-Tech Forensics, Inc.UC-12020-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
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10850074089091SurgycoSurgyco LLCJKA2025-12-23
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