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Stat Profile

FDA UDI

Class I (US FDA UDI)

by Nova Biomedical Corporation

Identity

Trade Name
STAT PROFILE FDA UDI
Generic Name
Assisted reproduction centrifuge tube FDA UDI
Device Name
Stat Profile pHOx Ultra/CCX Control Chemistry L4, 5 (amps) FDA UDI
Model / Reference
phox ultra/ccx FDA UDI
Description
Stat Profile pHOx Ultra/CCX Control Chemistry L4, 5 (amps) FDA UDI

Identifiers

Catalog Number
49184 FDA UDI
Primary DI / UDI-DI
00385480491846 FDA UDI
510(k) Number
K110648 FDA UDI
FDA Product Code
JJY FDA UDI
GMDN Term
Assisted reproduction centrifuge tube FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 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

Yes

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

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: Assisted reproduction centrifuge tube

Stat Profile by Nova Biomedical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assisted reproduction centrifuge tube.

Cleared under the same submission

K110648 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nova Biomedical Corporation

Sources (1)

  • FDA UDI ad726488-09d9-41dd-82a1-e404ab5efc5c 37 fields · synced Jun 8, 2026