Enable Blood Spot Collection Kit

FDA UDI

Class II (US FDA UDI)

by Enable Biosciences

Identity

Trade Name: Enable Blood Spot Collection Kit FDA UDI
Generic Name: Capillary blood collection kit IVD FDA UDI
Device Name: Sample Collection Kit Dried Blood Spot and Kit Accessories FDA UDI
Model / Reference: EBCK1 FDA UDI
Description: Sample Collection Kit Dried Blood Spot and Kit Accessories FDA UDI

Identifiers

Primary DI / UDI-DI: 00860010987803 FDA UDI
FDA Product Code: PQD FDA UDI
GMDN Term: Capillary blood collection kit IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1675 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Capillary blood collection kit IVD

Enable Blood Spot Collection Kit by Enable Biosciences — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Enable Biosciences

Sources (1)

FDA UDI 7e7f7c77-201e-4f39-86cb-ce5b12c2d245 33 fields · synced May 30, 2026