FDA.reportPublic FDA data

PRAS Bacteroides Bile Esculin (BBE)

Primary DI
00810048900053
Brand
PRAS Bacteroides Bile Esculin (BBE)
Company
ANAEROBE SYSTEMS
Model
AS-144
Catalog number
AS-144
Device description
AS-144 Bacteroides Bile Esculin (BBE) agar is an enriched, selective, and differential medium used for the isolation and presumptive identification of obligately anaerobic gram-negative bacilli of the Bacteroides fragilis group and Bilophila wadsworthia. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Transparent yellow/green. 4 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
JSICulture Media, Selective And Differential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSICulture Media, Selective And DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810048900053PrimaryGS10
00810048901500Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810048900053008100489000538100489000530810048900053
00810048901500008100489015008100489015000810048901500

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective agar culture medium IVDAn agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

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
4
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
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
00810048900220PRAS Mitis Salivarius Agar with Tellurite (MSAT)AS-544AS-5442020-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B645T0496EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B645T0577EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B645T0762EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-21
B6454P290EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P360EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P371EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P372EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454P401EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454Q194EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6454T207EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B645T0432EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-18
B6451P206EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6451R111EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6451R180EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6453P140EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P155EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P156EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P375EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B6454P376EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
B645T0236EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.JSI2025-04-17
10382902978821BD BBL™ Pseudosel™ Agar (Cetrimide Agar)BECTON, DICKINSON AND COMPANYJSI2024-09-19
10382902149825BD BBL™ CHROMagar™ Staph aureusBECTON, DICKINSON AND COMPANYJSI2024-08-28
00816576026968N/AHARDY DIAGNOSTICSJSI2024-07-08
10382902212789BD BBL™ Sabouraud Dextrose Agar (Deep Fill)BECTON, DICKINSON AND COMPANYJSI2023-11-17
10382902217807BD BBL™ Group A Selective Strep Agar with 5% Sheep Blood (BD ssA™)BECTON, DICKINSON AND COMPANYJSI2023-11-17
30382902214107BD BBL™ Bile Esculin Agar SlantsBECTON, DICKINSON AND COMPANYJSI2023-11-16
00848838001277REMELREMEL, INC.JSI2022-12-29
00848838001314REMELREMEL, INC.JSI2022-12-29
00848838001321REMELREMEL, INC.JSI2022-12-29
00848838001338REMELREMEL, INC.JSI2022-12-29