Culture Media, Single Biochemical Test

CTA (Cystine Tryptic Agar) with Xylose, 3ml fill, deep, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 Hardy Diagnostics CTA Media are…

Registry build 21.09.26

CTA (Cystine Tryptic Agar) with Xylose, 3ml fill, deep, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 Hardy Diagnostics CTA Media are recommended for the determination of carbohydrate fermentation by fastidious organisms such as Neisseria spp. They are also used for the detection of bacterial motility and serve as a culture media for microorganism maintenance.

2manufacturers in China registered for this device type
69catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (1), Shandong (1).

Chinese manufacturers registered for FDA product code JSF
Manufacturer City Province Registered as Device types
Bioteke Corporation (Wuxi) Co., Ltd. Wuxi Jiangsu Manufacturer 21
HBH Biotechnology Limited Yantai Shandong Repacker / relabeller 6

Record

Regulatory record for Culture Media, Single Biochemical Test
Listed by Hardy Diagnostics, United States
FDA product code JSF
Device type Culture Media, Single Biochemical Test
Device class Class 1
Regulation 21 CFR 866.2320
Establishment Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k) K880118
Record published 2020-05-24
Record revised 2023-08-22 (version 2)

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 2 to 8 °C
Distribution end date 2026-01-29

Catalogue Numbers

Catalogue numbers for Culture Media, Single Biochemical Test
Catalogue number Size Per pack Status
Y57 20 In distribution
Y315 20 In distribution
Y42 20 In distribution
Y14 20 In distribution
K93 20 In distribution
R97 20 In distribution
Y24 20 In distribution
R14 20 In distribution
Y25 20 In distribution
Y301 20 In distribution
Z205 20 In distribution
Y309 20 In distribution
Q09 20 In distribution
Y322 20 In distribution
Y319 20 In distribution
K237 20 In distribution
Y13 20 In distribution
Y12 20 In distribution
Y53 20 In distribution
Y311 20 In distribution
K279 20 In distribution
Y302 20 In distribution
Y20 20 In distribution
Y54 20 In distribution
Y19 20 In distribution
Y304 20 In distribution
K37 20 In distribution
Y55 20 In distribution
Y11 20 In distribution
Y314 20 In distribution
Y313 20 In distribution
Y56 20 In distribution
Y321 20 In distribution
Y317 20 In distribution
Y307 20 In distribution
Y43 20 In distribution
Y306 20 In distribution
Y44 20 In distribution
Y52 20 In distribution
Y312 20 In distribution
Z54 10 In distribution
K26 20 In distribution
L02 20 In distribution
Y16 20 In distribution
Y17 20 In distribution
Y23 20 In distribution
Y205 20 In distribution
L21 20 In distribution
Y58 20 In distribution
Y318 20 In distribution
R92 20 In distribution
Y316 20 In distribution
Y305 20 In distribution
R24 20 In distribution
Y15 20 In distribution
Z225 20 In distribution
K158 20 Withdrawn
L95 20 Withdrawn
Y126 20 Withdrawn
Y127 20 Withdrawn
Y310 20 Withdrawn
Y18 20 Withdrawn
Y128 20 Withdrawn
Y308 20 Withdrawn
K94 20 Withdrawn
Y130 20 Withdrawn
R135 20 Withdrawn
Y125 20 Withdrawn
Y10 20 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Remel Remel, Inc. 118
Redipor Analytichem USA, Inc. 8
BD BBL™ Moeller Decarboxylase Broth Base Becton, Dickinson AND Company 1
BD BBL™ CTA Medium™ Becton, Dickinson AND Company 1
BD BBL™ Moeller Decarboxylase Broth with Arginine Becton, Dickinson AND Company 1
LanaGram™ Hardy Diagnostics 1
BD BBL™ Moeller Decarboxylase Broth with Ornithine Becton, Dickinson AND Company 1
BD BBL™ CTA Medium™ with Sucrose Becton, Dickinson AND Company 1
Spot Indole Reagent (10ml) pro-lab incorporated 1
BD BBL™ CTA Medium™ with Lactose Becton, Dickinson AND Company 1
BD BBL™ Moeller Decarboxylase Broth with Lysine Becton, Dickinson AND Company 1

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer