← Back to catalogue

Procleix Tigris Lower Bay Fluids

FDA UDI

by Grifols Diagnostic Solutions Inc.

Identity

Trade Name
Procleix Tigris Lower Bay Fluids FDA UDI
Generic Name
Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD FDA UDI
Device Name
A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an assay using a nucleic acid technique (NAT) on a clinical specimen. FDA UDI
Model / Reference
Procleix Auto Detect Reagent Kit FDA UDI
Description
A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an assay using a nucleic acid technique (NAT) on a clinical specimen. FDA UDI

Identifiers

Primary DI / UDI-DI
00859882007368 FDA UDI
GMDN Term
Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD FDA UDI

Classification

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

Yes

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: Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD

Procleix Tigris Lower Bay Fluids by Grifols Diagnostic Solutions Inc. — 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
Grifols Diagnostic Solutions Inc.

Sources (1)

  • FDA UDI 664a478e-dc56-4783-a7eb-6cd09e887d8b 33 fields · synced Jun 9, 2026