← Back to catalogue

Hologic

FDA UDI

Class I (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
Hologic FDA UDI
Generic Name
Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD FDA UDI
Device Name
Universal General Purpose Reagent - Universal Arm1/Red FRET. FDA UDI
Model / Reference
UNIVERSAL ARM1/RED FRET FDA UDI
Description
Universal General Purpose Reagent - Universal Arm1/Red FRET. FDA UDI

Identifiers

Catalog Number
96-008 FDA UDI
Primary DI / UDI-DI
15420045506572 FDA UDI
FDA Product Code
PPM FDA UDI
GMDN Term
Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD 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 technique (NAT) chemiluminescent signal generation kit IVD

Hologic by Hologic, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD.

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
Hologic, Inc.

Sources (1)

  • FDA UDI f5e25535-aca7-40f5-b0f3-4c64e3042611 36 fields · synced Jun 1, 2026