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Procleix Babesia Assay

FDA UDI

by Grifols Diagnostic Solutions Inc.

Identity

Trade Name
Procleix Babesia Assay FDA UDI
Generic Name
Babesia microti nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens. FDA UDI
Model / Reference
Box 2 FDA UDI
Description
The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens. FDA UDI

Identifiers

Primary DI / UDI-DI
00859882007726 FDA UDI
GMDN Term
Babesia microti nucleic acid IVD, kit, nucleic acid technique (NAT) 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: Babesia microti nucleic acid IVD, kit, nucleic acid technique (NAT)

Procleix Babesia Assay by Grifols Diagnostic Solutions Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Babesia microti nucleic acid IVD, kit, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Grifols Diagnostic Solutions Inc.

Sources (1)

  • FDA UDI e8c380d1-9cf9-4727-a681-f46a305ab4e5 33 fields · synced Jun 9, 2026