Who else makes this device?

Name: Germ Tube Cryo™
Brand: Germ Tube Cryo™

Immunology & Microbiology › Microbiology DevicesDiscs, Strips And Reagents, Microorganism Differentiation

Germ Tube Cryo™

Germ Tube Cryo™, for Candida albicans, 0.5ml, ready to use, 20 vials per package A ready-to-use germ tube solution made up of stabilized animal serum, comes pre-measured in vials. No…

Registry build 21.09.26

Germ Tube Cryo™, for Candida albicans, 0.5ml, ready to use, 20 vials per package A ready-to-use germ tube solution made up of stabilized animal serum, comes pre-measured in vials. No mixing, measuring, or aliquoting is required! Eliminates exposure to human serum. 0.5ml in each vial. Germ tubes develop on C. albicans within one hour. Serum formula is enhanced for more rapid and luxuriant production of germ tubes.

4manufacturers in China registered for this device type

1catalogue number

10510(k) clearances naming this product code

1recall

Who Else Makes It

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

Chinese manufacturers registered for FDA product code JTO
Manufacturer	City	Province	Registered as	Device types
Hospital & Homecare IMP. & EXP. Co., Ltd.	Nanjing	Jiangsu	Contract manufacturer	179
Jinan Babio Biotechnology Co., Ltd.	Jinan	Shandong	Manufacturer	25
Changchun LYZ Technology Co., Ltd.	Changchun	Jilin	Manufacturer	16
Zhejiang Joozena Medical Technology Co., Ltd.	Dongyang City, Jinhua	Zhejiang	Manufacturer	5

Record

Regulatory record for Germ Tube Cryo™
Listed by	Hardy Diagnostics, United States
FDA product code	JTO
Device type	Discs, Strips And Reagents, Microorganism Differentiation
Device class	Class 1
Regulation	21 CFR 866.2660
Establishment	Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2020-08-20

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 -2 °C

Catalogue Numbers

Catalogue numbers for Germ Tube Cryo™
Catalogue number	Size	Per pack	Status
Z217		20	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Remel	Remel, Inc.	62
Discs, Strips And Reagents, Microorganism Differentiation	Hardy Diagnostics	37
HardyDisk™	Hardy Diagnostics	17
Bactidrop	Remel, Inc.	10
Redipor	Analytichem USA, Inc.	7
BD BBL™ Taxo™ P	Becton, Dickinson AND Company	4
BD BBL™ Taxo™ A	Becton, Dickinson AND Company	4
API® NaCl 0.85% Medium	bioMerieux, Inc.	3
Bacticard	Remel, Inc.	3
Chemmette Reagents	Microbiologics, Inc.	2
Optochin	Oxoid, Ltd.	2
X Factor	Oxoid, Ltd.	2

Showing 12 of 139. All products under Discs, Strips And Reagents, Microorganism Differentiation

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K961191	1996-06-17
K960996	1996-04-18
K931865	1993-12-15
K931862	1993-06-15
K931414	1993-05-12
K930693	1993-05-12
K931413	1993-05-11
K930717	1993-04-23
K930718	1993-04-23
K930720	1993-04-23

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2003-12-31	Not classified	Other	Mislabeled.	39 bottles of Z71 and 6 bottles of Z72	2004-05-17

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.