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MicroScan

FDA UDI

Class II (US FDA UDI)

by Beckman Coulter, Inc.

Identity

Trade Name
MicroScan FDA UDI
Generic Name
General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI
Device Name
Pos MIC Panel Type 29 FDA UDI
Model / Reference
B1017-212 FDA UDI
Description
Pos MIC Panel Type 29 FDA UDI

Identifiers

Primary DI / UDI-DI
15099590657536 FDA UDI
510(k) Number
K003619 FDA UDI
K010418 FDA UDI
K020160 FDA UDI
K020162 FDA UDI
K043545 FDA UDI
K050043 FDA UDI
K051202 FDA UDI
K081013 FDA UDI
K081182 FDA UDI
K091264 FDA UDI
K862140 FDA UDI
K863776 FDA UDI
K870074 FDA UDI
K874876 FDA UDI
K883076 FDA UDI
K934323 FDA UDI
K945235 FDA UDI
K972688 FDA UDI
K972799 FDA UDI
K993102 FDA UDI
FDA Product Code
LTW FDA UDI
LRG FDA UDI
JWY FDA UDI
LTT FDA UDI
GMDN Term
General-microorganism antimicrobial susceptibility culture medium IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.1640 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

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

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: General-microorganism antimicrobial susceptibility culture medium IVD

MicroScan by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-microorganism antimicrobial susceptibility culture medium IVD.

Cleared under the same submission

K003619 also covers:

K010418 also covers:

K020160 also covers:

K020162 also covers:

K043545 also covers:

K050043 also covers:

K081013 also covers:

K081182 also covers:

K091264 also covers:

K862140 also covers:

K863776 also covers:

K870074 also covers:

K874876 also covers:

K883076 also covers:

K934323 also covers:

K945235 also covers:

K972688 also covers:

K972799 also covers:

K993102 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Beckman Coulter, Inc.

Sources (1)

  • FDA UDI d5ee5eda-96f3-4c72-9ff7-b2745e55217b 34 fields · synced Jun 8, 2026