FDA.reportPublic FDA data

PRAS Brucella Agar Deep CLSI Formulation 19mL (BRU DEEP CLSI 19mL)

Primary DI
00810048901371
Brand
PRAS Brucella Agar Deep CLSI Formulation 19mL (BRU DEEP CLSI 19mL)
Company
ANAEROBE SYSTEMS
Model
AS-808
Catalog number
AS-808
Device description
AS-808 Brucella Agar Deep CLSI 19 mL (BRU DEEP CLSI 19mL), with the addition of blood, is intended for the isolation, quantitation, and partial identification of obligate anaerobic bacteria from clinical specimens. This media will support the growth of aerobic and microaerophilic bacteria if incubated appropriately. Pre-reduced anaerobically sterilized (PRAS). 19 mL fill volume. 20 x 113 mm screw top tube. Translucent yellow. 10 tubes 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
JSGCulture Media, Non-Selective And Non-Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSGCulture Media, Non-Selective And Non-DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810048901371PrimaryGS10
00810048901876Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810048901371008100489013718100489013710810048901371
00810048901876008100489018768100489018760810048901876

GMDN Terms#

Term, Definition table
TermDefinition
Basic/simple nutrient agar culture medium IVDA non-selective, non-differential nutrient agar culture medium containing intended to be used for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
021192653
Device count
10
Premarket exempt
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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