← Back to catalogue

Nova

FDA UDI

Class I (US FDA UDI)

by Nova Biomedical Corporation

Identity

Trade Name
NOVA FDA UDI
Generic Name
Buffered sample diluent IVD, manual FDA UDI
Device Name
Nova 1/4/5/8/10/11/13 Dilutor Pack FDA UDI
Model / Reference
1/4/5/8/10/11/13 FDA UDI
Description
Nova 1/4/5/8/10/11/13 Dilutor Pack FDA UDI

Identifiers

Catalog Number
12882 FDA UDI
Primary DI / UDI-DI
00385480128827 FDA UDI
FDA Product Code
CFA FDA UDI
NDW FDA UDI
JGS FDA UDI
CHL FDA UDI
JFP FDA UDI
JPI FDA UDI
JFL FDA UDI
CGZ FDA UDI
CEM FDA UDI
GMDN Term
Buffered sample diluent IVD, manual FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1495 FDA UDI
862.3560 FDA UDI
862.1665 FDA UDI
862.1120 FDA UDI
862.1145 FDA UDI
864.6400 FDA UDI
862.1160 FDA UDI
862.1170 FDA UDI
862.1600 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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: Buffered sample diluent IVD, manual

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

Similar devices

Also classified as Buffered sample diluent IVD, manual.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Nova Biomedical Corporation

Sources (1)

  • FDA UDI 7619e500-a4a8-4ac9-920a-1047ff4ebb3c 36 fields · synced Jun 8, 2026