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XpressCollect TM Sterile Polyester Spun Swab in Tube 100 ea.

FDA UDI

Class I (US FDA UDI)

by Steripack Usa (limited) Llc

Identity

Trade Name
XpressCollect TM Sterile Polyester Spun Swab in Tube 100 ea. FDA UDI
Generic Name
Hu antibody (anti-Hu) IVD, kit, fluorescent immunoassay FDA UDI
Device Name
single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares FDA UDI
Model / Reference
60601 FDA UDI
Description
single use, sterile pouched polyester spun swabs for specimen ciollection sampling from nasal area, i.e. Anterior nares FDA UDI

Identifiers

Primary DI / UDI-DI
00850027193045 FDA UDI
FDA Product Code
KXG FDA UDI
GMDN Term
Hu antibody (anti-Hu) IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6025 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Hu antibody (anti-Hu) IVD, kit, fluorescent immunoassay

XpressCollect TM Sterile Polyester Spun Swab in Tube 100 ea. by Steripack Usa (limited) Llc — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Hu antibody (anti-Hu) IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Steripack Usa (limited) Llc

Sources (1)

  • FDA UDI ab626662-3b07-40b0-b6c3-895ab46461db 33 fields · synced Jun 8, 2026