FDA.reportPublic FDA data

PRAS BRU PEA LKV Convenience Pack

Primary DI
00810048901302
Brand
PRAS BRU PEA LKV Convenience Pack
Company
ANAEROBE SYSTEMS
Model
AS-303
Catalog number
AS-303
Device description
AS-303 BRU, PEA, and LKV Convenience Pack - Includes 1 Brucella Blood Agar (BRU), 1 Phenylethyl Alcohol Blood Agar, and 1 Laked Brucella Blood Agar with Kanamycin and Vancomycin (LKV). Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. BRU is opaque burgundy red. PEA is opaque red. LKV is transparent red. 3 plates per pack.
Published
2020-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSHCulture Media, Non-Selective And Differential
JSICulture Media, Selective And Differential
JSJCulture Media, Selective And Non-Differential
KZICulture Media, Enriched

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSHCulture Media, Non-Selective And DifferentialMicrobiology1
JSICulture Media, Selective And DifferentialMicrobiology1
JSJCulture Media, Selective And Non-DifferentialMicrobiology1
KZICulture Media, EnrichedMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810048901302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810048901302008100489013028100489013020810048901302

GMDN Terms#

Term, Definition table
TermDefinition
Multiple formulation agar culture medium IVDA combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-443-3108customerservice@anaerobesystems.com

Regulatory Flags#

DUNS number
021192653
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810048902477PRAS Peptone Yeast Extract Broth w/ Glucose & Formate/Fumarate AS-858AS-8582022-01-01
00810048902491PRAS Peptone Yeast Extract Broth w/ Lactate (PY LACTATE)AS-846AS-8462022-01-01
00810048902514PRAS Peptone Yeast Extract Broth w/ Glucose & Tween 80 (PYG TWEEN)AS-825AS-8252022-01-01
00810048902460PRAS Peptone Yeast Extract Broth w/ Glucose & Formate/Fumarate AS-858AS-8582022-01-01
00810048902484PRAS Peptone Yeast Extract Broth w/ Lactate (PY LACTATE)AS-846AS-8462022-01-01
00810048902507PRAS Peptone Yeast Extract Broth w/ Glucose & Tween 80 (PYG TWEEN)AS-825AS-8252022-01-01
00810048900763PRAS Peptone Yeast Extract Broth w/ Glucose & Tween 80 FA/GLC (PYG TWEEN FA/GLC)AS-825AS-8252020-05-01
00810048901135PRAS Peptone Yeast Extract Broth w/ Lactate FA/GLC (PY LACTATE FA/GLC)AS-846AS-8462020-05-01
00810048901142PRAS Peptone Yeast Extract Broth w/ Glucose & Formate/Fumarate FA/GLC AS-858AS-8582020-05-01
00810048900015PRAS Brucelle Blood Agar (BRU)AS-141AS-1412020-05-01
00810048900039PRAS Laked Brucella Blood Agar w/ Kanamycin & Vancomycin (LKV)AS-142AS-1422020-05-01
00810048900053PRAS Bacteroides Bile Esculin (BBE)AS-144AS-1442020-05-01
00810048900077PRAS Phenylethyl Alcohol Blood Agar (PEA)AS-143AS-1432020-05-01
00810048900084PRAS Brucella Broth (BRU BROTH)AS-105AS-1052020-05-01
00810048900114PRAS BBE/LKV BiplateAS-242AS-2422020-05-01
00810048900169PRAS Chocolate Agar (CHOC)AS-244AS-2442020-05-01
00810048900176PRAS Botulism Selective Medium (BSM)AS-223AS-2232020-05-01
00810048900183PRAS Tryptic Soy Agar with Tween® and Lecithin (TSA-TL)AS-228AS-2282020-05-01
00810048900190PRAS Yeast Malt Extract Agar (YMEA)AS-229AS-2292020-05-01
00810048900213PRAS Tryptic Soy Blood Agar (TSBA)AS-542AS-5422020-05-01

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