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Amplichek

FDA UDI

Class II (US FDA UDI)

by Bio-Rad Laboratories

Identity

Trade Name
Amplichek FDA UDI
Generic Name
MRSA nucleic acid IVD, control FDA UDI
Device Name
Amplichek II Level 3 (A nucleic acid control.) FDA UDI
Model / Reference
12000204 FDA UDI
Description
Amplichek II Level 3 (A nucleic acid control.) FDA UDI

Identifiers

Catalog Number
12000204 FDA UDI
Primary DI / UDI-DI
00847661005957 FDA UDI
510(k) Number
DEN150058 FDA UDI
FDA Product Code
PMN FDA UDI
GMDN Term
MRSA nucleic acid IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3920 FDA UDI
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

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: Clostridium difficile nucleic acid IVD, controlMRSA nucleic acid IVD, controlVancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control

Amplichek by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vancomycin-resistant Enterococcus (VRE) culture isolate nucleic acid IVD, control.

Cleared under the same submission

DEN150058 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio-Rad Laboratories

Sources (1)

  • FDA UDI f8e420e6-1b30-4580-be73-4d9eafc8cfb2 37 fields · synced May 31, 2026