FDA.report

PRAS Peptone Yeast Extract Broth w/ Lactate FA/GLC (PY LACTATE FA/GLC)

Primary DI
00810048902170
Brand
PRAS Peptone Yeast Extract Broth w/ Lactate FA/GLC (PY LACTATE FA/GLC)
Company
ANAEROBE SYSTEMS
Model
AS-846
Catalog number
AS-846
Device description
AS-846 Peptone Yeast Extract Broth with Lactate FA/GLC (PY LACTATE FA/GLC) is designed for the determination of lactate fermentation by anaerobic bacteria for identification. PY LACTATE FA/GLC is recommended for use in identifying Veillonella species within the MIDI MIS procedures. Pre-reduced anaerobically sterilized (PRAS). 10 mL fill volume. 16 x 100 mm hungate-capped tube. Transparent golden 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

Product Codes

CodeName
JSCCulture Media, General Nutrient Broth

Product Code Classifications

CodeDeviceSpecialtyClass
JSCCulture Media, General Nutrient BrothMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810048901135PrimaryGS10
00810048902170Unit of UseGS10

GMDN Terms

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

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
00810048900008PRAS Brucella Blood Agar (BRU)AS-111AS-1112020-05-01
00810048901470PRAS Brucelle Blood Agar (BRU)AS-141AS-1412020-05-01
00810048900022PRAS Laked Brucella Blood Agar w/ Kanamycin & Vancomycin (LKV)AS-112AS-1122020-05-01
00810048901487PRAS Laked Brucella Blood Agar w/ Kanamycin & Vancomycin (LKV)AS-142AS-1422020-05-01
00810048900046PRAS Bacteroides Bile Esculin Agar (BBE)AS-114AS-1142020-05-01
00810048901500PRAS Bacteroides Bile Esculin (BBE)AS-144AS-1442020-05-01
00810048900060PRAS Phenylethyl Alcohol Blood Agar (PEA)AS-113AS-1132020-05-01
00810048901494PRAS Phenylethyl Alcohol Blood Agar (PEA)AS-143AS-1432020-05-01
00810048901463PRAS Brucella Broth (BRU BROTH)AS-105AS-1052020-05-01
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
00810048900145PRAS Cycloserine Cefoxitin Fructose Agar w/ Horse Blood & Taurocholate (CCFA-HT)AS-2136AS-21362020-05-01
00810048900152PRAS Chocolate Agar (CHOC)AS-214AS-2142020-05-01
00810048901555PRAS Chocolate Agar (CHOC)AS-244AS-2442020-05-01

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