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Ish Negative Control

FDA UDI

Class I (US FDA UDI)

by Ventana Medical Systems

Identity

Trade Name
ISH NEGATIVE CONTROL FDA UDI
Generic Name
Nucleic acid hybridization detection IVD, control FDA UDI
Model / Reference
05272165001 FDA UDI

Identifiers

Catalog Number
05272165001 FDA UDI
Primary DI / UDI-DI
04015630971718 FDA UDI
FDA Product Code
PPM FDA UDI
GMDN Term
Nucleic acid hybridization detection IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.4010 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

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: Nucleic acid hybridization detection IVD, control

Ish Negative Control by Ventana Medical Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nucleic acid hybridization detection IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ventana Medical Systems

Sources (1)

  • FDA UDI b84c4103-208d-40a9-974c-9b4e53165271 33 fields · synced Jun 8, 2026