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Paternity Test Kit 1

FDA UDI

Class I (US FDA UDI)

by Ditek Consulting Llc

Identity

Trade Name
Paternity Test Kit 1 FDA UDI
Generic Name
Oral/upper respiratory tract specimen collection kit IVD, clinical FDA UDI
Device Name
Paternity Test Kit 1 Single test FDA UDI
Model / Reference
96835 FDA UDI
Description
Paternity Test Kit 1 Single test FDA UDI

Identifiers

Primary DI / UDI-DI
00860013899271 FDA UDI
FDA Product Code
NNK FDA UDI
GMDN Term
Oral/upper respiratory tract specimen collection kit IVD, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Oral/upper respiratory tract specimen collection kit IVD, clinical

Paternity Test Kit 1 by Ditek Consulting Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral/upper respiratory tract specimen collection kit IVD, clinical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ditek Consulting Llc

Sources (1)

  • FDA UDI e60a3121-f21e-4b5f-8188-b2f8e2dd67df 33 fields · synced Jun 6, 2026