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Remel

FDA UDI

Class I (US FDA UDI)

by Remel, Inc.

Identity

Trade Name
Remel FDA UDI
Generic Name
Staphylococcus aureus culture isolate antigen IVD, kit, agglutination FDA UDI
Device Name
BactiStaph Latex 450TST/KT FDA UDI
Model / Reference
R21143 FDA UDI
Description
BactiStaph Latex 450TST/KT FDA UDI

Identifiers

Primary DI / UDI-DI
00848838022982 FDA UDI
FDA Product Code
JWX FDA UDI
GMDN Term
Staphylococcus aureus culture isolate antigen IVD, kit, agglutination FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.2660 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Staphylococcus aureus culture isolate antigen IVD, kit, agglutination

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

Similar devices

Also classified as Staphylococcus aureus culture isolate antigen IVD, kit, agglutination.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Remel, Inc.

Sources (1)

  • FDA UDI 2e7fd75d-0028-455d-8a98-18a9814acd24 34 fields · synced Jun 8, 2026