Who else makes this device?

Name: Pras Enriched Tryptic Soy Agar with Nalidixic Acid and Vancomycin (Etsa-NV)
Brand: Pras Enriched Tryptic Soy Agar with Nalidixic Acid and Vancomycin (Etsa-NV)

Immunology & Microbiology › Microbiology DevicesCulture Media, Selective And Differential

Pras Enriched Tryptic Soy Agar With Nalidixic Acid and Vancomycin (Etsa-NV)

AS-549 Enriched Tryptic Soy Agar with Nalidixic Acid and Vancomycin (ETSA-NV) is an enriched, selective, and differential medium intended for the cultivation and isolation of most…

Registry build 21.09.26

AS-549 Enriched Tryptic Soy Agar with Nalidixic Acid and Vancomycin (ETSA-NV) is an enriched, selective, and differential medium intended for the cultivation and isolation of most gram-negative anaerobic and other fastidious bacteria. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. Transparent yellow/red. 4 plates per pack.

1manufacturer

1catalogue number

12510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code JSI
Manufacturer	City	Province	Registered as	Device types
Guangdong Huankai Biology SCI.&Tech.co., Ltd.	Zhaoqing	Guangdong	Manufacturer	2

Record

Regulatory record for Pras Enriched Tryptic Soy Agar with Nalidixic Acid and Vancomycin (Etsa-NV)
Listed by	Anaerobe Systems, United States
FDA product code	JSI
Device type	Culture Media, Selective And Differential
Device class	Class 1
Regulation	21 CFR 866.2360
Establishment	Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2020-05-01

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 20 to 25 °C

Catalogue Numbers

Catalogue numbers for Pras Enriched Tryptic Soy Agar with Nalidixic Acid and Vancomycin (Etsa-NV)
Catalogue number	Size	Per pack	Status
AS-549		4	In distribution

Same Product Code

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HardyCHROM	Hardy Diagnostics	11
AnaeroGRO	Hardy Diagnostics	5
BD BBL™ Sabouraud Dextrose Agar Slants	Becton, Dickinson AND Company	2
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Pras Laked Brucella Blood Agar w/ Kanamycin & Vancomycin (LKV)	Anaerobe Systems	2
BD BBL™ Bile Esculin Agar Slants	Becton, Dickinson AND Company	2
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BD BBL™ Hektoen Enteric Agar	Becton, Dickinson AND Company	2

Showing 12 of 97. All products under Culture Media, Selective And Differential

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K841218	1984-04-05
K841142	1984-04-05
K841222	1984-04-04
K841141	1984-03-26
K841134	1984-03-26
K841131	1984-03-23
K841129	1984-03-23
K841132	1984-03-23
K791563	1979-09-17
K791579	1979-09-17
K790624	1979-04-23
K790628	1979-04-23

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.