FDA.reportPublic FDA data

Specimen Collection Kit

Primary DI
00860013969561
Brand
Specimen Collection Kit
Company
Ditek Consulting, LLC
Model
146345
Device description
Specimen Collection Kit
Published
2025-10-13
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
00860013969561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013969561008600139695618600139695610860013969561

GMDN Terms#

Term, Definition table
TermDefinition
Phlebotomy kitA collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011770282Kidney Stone Collection Kit1462252025-09-11
00860013969554Ditek BioBank Kit (Labcorp)1460452025-08-28
00860013969547High Altitude QuantiFERONTest Kit1217272025-06-17
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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10885380212017Aero-MedAERO-MED, LLCOIB2026-06-04
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