FDA.reportPublic FDA data

Anaerobic Catalase Reagent - 15% Hydrogen Peroxide

Primary DI
00810048900527
Brand
Anaerobic Catalase Reagent - 15% Hydrogen Peroxide
Company
ANAEROBE SYSTEMS
Model
AS-708
Catalog number
AS-708
Device description
AS-708 Anaerobic Catalase Reagent - 15% Hydrogen Peroxide is used to determine if an organism is producing catalase and/or peroxidase. 30 mL fill volume. 30 mL dropping bottle. 1 bottler per pack.
Published
2020-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JTODiscs, Strips And Reagents, Microorganism Differentiation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTODiscs, Strips And Reagents, Microorganism DifferentiationMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810048900527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810048900527008100489005278100489005270810048900527

GMDN Terms#

Term, Definition table
TermDefinition
Catalase production microbial reagent IVDA substance or reactant, sometimes referred to as hydrogen peroxide reagent, intended to be used in microbial testing to detect the enzyme catalase produced by a microorganism isolated from a clinical specimen by culture.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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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