Path-Tec

FDA Device Registration & Listing · Midland, GA, US · Registration 3007871198

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007871198
FEI Number
3007871198
Entity Name
Path-Tec
City/State/Country
Midland, GA, US
Establishment Address
5700 Old Brim Rd, Midland, GA 31820, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
BioTouch Global / Path-tec (Owner Number: 10024021)
Owner / Operator Contact Address
5700 Old Brim Road, Midland, GA 31820, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Cytology Transport Kit Blood Alcohol Collection Kit Urine Transport Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
SBB System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection Unknown Class 3 N/A 2025-09-26
OKY Cytology Kit Obstetrics/Gynecology Class 2 884.4530 2009-08-20
OIC Blood Alcohol Kit (Excludes Hiv Testing) Clinical Toxicology Class 2 862.3040 2009-08-20
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2023-03-28
PUD Labware, Assisted Reproduction, Exempt Obstetrics/Gynecology Class 2 884.6160 2025-03-25
OHZ Urine Transport Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2009-08-20

Official Correspondent

Jennifer Block

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BioTouch Global / Path-tec
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007871198. Last updated year: 2026. Please use registration number 3007871198 when referencing this establishment in official correspondence.
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