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PRAS BRU, BBE/LKV (2 plates /pkg)

EUDAMEDFDA UDI

Class A (EU MDR)

Ref AS-302

by Anaerobe Systems

Identity

Trade Name
PRAS BRU, BBE/LKV (2 plates /pkg) EUDAMED
PRAS BRU BBE/LKV Convenience Pack FDA UDI
Generic Name
Multiple formulation agar culture medium IVD FDA UDI
Device Name
Anaerobic Culture Media EUDAMED
AS-302 BRU and BBE/LKV Convenience Pack - Includes 1 Brucella Blood Agar (BRU) and 1 Bacteroides Bile Esculin Agar (BBE)/Laked Brucella Blood Agar with Kanamycin and Vancomycin (LKV) Biplate. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. BRU is opaque burgundy red. BBE is transparent yellow/green. LKV is transparent red. 2 plates per pack. FDA UDI
Model / Reference
AS-302 EUDAMEDFDA UDI
Description
AS-302 BRU and BBE/LKV Convenience Pack - Includes 1 Brucella Blood Agar (BRU) and 1 Bacteroides Bile Esculin Agar (BBE)/Laked Brucella Blood Agar with Kanamycin and Vancomycin (LKV) Biplate. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. BRU is opaque burgundy red. BBE is transparent yellow/green. LKV is transparent red. 2 plates per pack. FDA UDI

Identifiers

Catalog Number
AS-302 FDA UDI
Primary DI / UDI-DI
00810048901296 EUDAMEDFDA UDI
Basic UDI-DI
081004890ANAEROBEDT EUDAMED
FDA Product Code
KZI FDA UDI
JSH FDA UDI
JSJ FDA UDI
JSI FDA UDI
EMDN Code
W0104010405 NON-CHROMOGENIC MEDIA (PLATES) EUDAMED
GMDN Term
Multiple formulation agar culture medium IVD FDA UDI

Classification

Device Class
Class A EUDAMED
Class I FDA UDI
Regulation Number
866.2330 FDA UDI
866.2320 FDA UDI
866.2360 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

PRAS BRU, BBE/LKV (2 plates /pkg) by Anaerobe Systems — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Anaerobe Systems
EUDAMED SRN
US-MF-000040030
Authorised Representative
Casus Europe B.V. NL-AR-000037688

Sources (2)

  • EUDAMED ab6b7119-7da5-4601-89a0-778157884774 61 fields · synced Jun 17, 2026
  • FDA UDI 7c539bc3-efff-42f3-9a61-540cd29f05b8 36 fields · synced May 30, 2026