FDA.reportPublic FDA data

High Altitude QuantiFERONTest Kit

Primary DI
00860013969547
Brand
High Altitude QuantiFERONTest Kit
Company
Ditek Consulting, LLC
Model
121727
Device description
High Altitude QuantiFeron Test Kit
Published
2025-06-17
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
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860013969544PackageGS124In Commercial Distribution
00860013969547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001396954410860013969544
00860013969547008600139695478600139695470860013969547

GMDN Terms#

Term, Definition table
TermDefinition
General specimen receptacle transport containerA non-powered portable device designed for the transportation of clinical specimens contained within receptacles (e.g., glass vials, bottles, tubes, slides, swabs) from the point of collection to the laboratory or between medical institutions. It is typically designed to be liquid-tight with a shock-absorbing foam liner to protect the contents from adverse conditions that could cause breakage and to absorb any escaped fluid. It is available in a variety of designs whereby it may be thermally insulated and might include a non-powered cold pack(s). This is a reusable device.

Regulatory Flags#

DUNS number
111296701
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013969561Specimen Collection Kit1463452025-10-13
00860011770282Kidney Stone Collection Kit1462252025-09-11
00860013969554Ditek BioBank Kit (Labcorp)1460452025-08-28
10860013969544High Altitude QuantiFERONTest Kit1217272025-06-17
00860013969530NMS Umbilical Cord Kit380371G2025-06-09
00860013899264Paternity Test Kit 50469332025-05-06
00860013899288Paternity Test Kit 25926962025-05-06
10860013899261Paternity Test Kit 50469332025-05-06
00860013899271Paternity Test Kit 1968352025-05-06
10860013899285Paternity Test Kit 25926962025-05-06
00860013899295Colofit Test KitDTCF012025-05-06
00860013969509Kidney Combo Test Kit 1KHK012025-05-06
00860013969516Kidney Health Test Kit 2 eGFR012025-05-06
00860013969523Kidney Health Test Kit 3uACR012025-05-06
00860011770268Covid 19 Testing Kit1413142025-05-01
00860011770220NIPS Single Pack Testing Kit1163732025-05-01
10860011770265Covid 19 Testing Kit1413142025-05-01
10860011770203Alzheimer's Evalutation CSF Kit1408572025-05-01
20860011770231NIPS Combo Collection Kit1312612025-05-01
10860009616018Adult Blood Culture Collection Kit1251842024-11-13

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