FDA.report

PRAS Indole Nitrate Broth

Primary DI
00810048902323
Brand
PRAS Indole Nitrate Broth
Company
ANAEROBE SYSTEMS
Model
AS-861
Catalog number
AS-861
Device description
AS-861 Indole Nitrate Broth is a nonselective broth used for the detection of indole production and nitrate reduction by a microorganism. Pre-reduced anaerobically sterilized (PRAS). 7 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent light yellow liquid. 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
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JSCCulture Media, General Nutrient Broth

Product Code Classifications

CodeDeviceSpecialtyClass
JSCCulture Media, General Nutrient BrothMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810048901098PrimaryGS10
00810048902323Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810048901098008100489010988100489010980810048901098
00810048902323008100489023238100489023230810048902323

GMDN Terms

TermDefinition
Indole broth/peptone water microbial reagent IVDA substance or reactant, sometimes referred to as indole broth or peptone water, intended to be used in the testing of a microorganism isolated from a clinical specimen by culture, to detect the presence of enzymes that split indole from the amino acid tryptophan.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-443-3108customerservice@anaerobesystems.com

Regulatory Flags

DUNS number
021192653
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00810048900091PRAS Campylobacter Selective Agar (CAMPY)AS-211AS-2112020-05-01
00810048900107PRAS BBE/LKV BiplateAS-212AS-2122020-05-01
00810048901548PRAS BBE/LKV BiplateAS-242AS-2422020-05-01
00810048900121PRAS Cycloserine Cefoxitin Fructose Agar (CCFA) AS-213AS-2132020-05-01
00810048900138PRAS Cycloserine Cefoxitin Fructose Agar with Lysozyme (CCFA-L)AS-2133AS-21332020-05-01
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