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Blood-Urine Specimen Kit

FDA UDI

Class II (US FDA UDI)

by Capitol Vial, Inc.

Identity

Trade Name
Blood-Urine Specimen Kit FDA UDI
Generic Name
Evacuated blood collection tube IVD, K3EDTA FDA UDI
Device Name
Quest Blood & Urine Box Kit FDA UDI
Model / Reference
SA94633 FDA UDI
Description
Quest Blood & Urine Box Kit FDA UDI

Identifiers

Catalog Number
SA94633 FDA UDI
Primary DI / UDI-DI
00859952006161 FDA UDI
FDA Product Code
JKA FDA UDI
GMDN Term
Evacuated blood collection tube IVD, K3EDTA 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

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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Evacuated blood collection tube IVD, K3EDTA

Blood-Urine Specimen Kit by Capitol Vial, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Evacuated blood collection tube IVD, K3EDTA.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Capitol Vial, Inc.

Sources (1)

  • FDA UDI 901e20f1-711a-48e0-8d93-4763a29d2464 35 fields · synced Jun 8, 2026