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Fresh Cells

FDA UDI

Class I (US FDA UDI)

by Diagnostic Hybrids, Inc.

Identity

Trade Name
Fresh Cells FDA UDI
Generic Name
Cell culture line IVD FDA UDI
Device Name
H&V MIX CELLS MWP 48/08 FILL FDA UDI
Model / Reference
98-4808DS FDA UDI
Description
H&V MIX CELLS MWP 48/08 FILL FDA UDI

Identifiers

Catalog Number
98-4808DS FDA UDI
Primary DI / UDI-DI
30014613335344 FDA UDI
FDA Product Code
KIR FDA UDI
GMDN Term
Cell culture line IVD FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.2280 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

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: Cell culture line IVD

Fresh Cells by Diagnostic Hybrids, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cell culture line IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagnostic Hybrids, Inc.

Sources (1)

  • FDA UDI 784887e9-eb86-4917-9708-1774a7840ee2 35 fields · synced Jun 8, 2026