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Bausch + Lomb

FDA UDI

Class I (US FDA UDI)

by Bausch & Lomb Incorporated

Identity

Trade Name
Bausch + Lomb FDA UDI
Generic Name
Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
FENEST'TR GUILFRD-WGHT NEW ANG FDA UDI
Model / Reference
X0750 21 FDA UDI
Description
FENEST'TR GUILFRD-WGHT NEW ANG FDA UDI

Identifiers

Catalog Number
X0750 21 FDA UDI
Primary DI / UDI-DI
00757770407712 FDA UDI
FDA Product Code
JYO FDA UDI
GMDN Term
Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, nephelometry/turbidimetry

Bausch + Lomb by Bausch & Lomb Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, nephelometry/turbidimetry.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bausch & Lomb Incorporated

Sources (1)

  • FDA UDI eabe8e95-e339-44ae-bd30-29140849e98f 34 fields · synced Jun 8, 2026