JTO

Product Code: JTO

Products Classified as JTO

3362

Discs, Strips And Reagents, Microorganism Differentiation

Microorganism Differentiation And Identification Device.

Total Product Life Cycle (TPLC) Devices

3362

Discs, Strips And Reagents, Microorganism Differentiation

Microorganism Differentiation And Identification Device.

FDA Consensus Standards

• Discs, Strips And Reagents, Microorganism Differentiation [30236]: 21 CFR §866.2660 🔎
• Discs, Strips And Reagents, Microorganism Differentiation [33208]: 21 CFR §866.2660 🔎

Pre-market Notifications for JTO

K050352	IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT	AMERITEK RESEARCH LLC
K970834	GRAM SWAB	REMEL, INC.
K970833	INDOLE SWAB	REMEL, INC.
K970832	PYR SWAB	REMEL, INC.
K970009	LYFO(TM) DIFFERENTIAL DISK-BACITRACIN	MICRO BIO LOGICS, INC.
K962966	IDS RAPID CB PLUS SYSTEM	INNOVATIVE DIAGNOSTIC SYSTEMS, INC.
K960996	M. CAT BUTYRATE DISK	HARDY DIAGNOSTICS
K955826	GIBSON ID-M. CAT.	GIBSON LABORATORIES, INC.
K954812	LYFO(TM) DIFFERIENTAL DISK-PYR	MICRO BIO LOGICS, INC.
K954783	DRYSLIDE CARTARRHALIS	DIFCO LABORATORIES, INC.
K953247	GIBSON ID A.E. TEST	GIBSON LABORATORIES, INC.
K951889	LYFO(TM) DIFFERENTIAL DISK	MICRO BIO LOGICS, INC.
K950346	B-L RED(TM) DISCS	OXIS INTL., INC.
K945882	LYFO(TM) DIFFERENTIAL DISK-BILE	MICRO BIO LOGICS, INC.
K945883	LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN	MICRO BIO LOGICS, INC.

Global Unique Device Identification Database

• 00382902317500: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 00382902317470: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 00382902317425: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 00382902317418: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 00382902317371: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 00382902317357: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 00382902317340: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 00382902317319: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 00382902317296: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 00382902317272: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 00382902317265: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 00382902317258: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 00382902317234: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 00382902316510: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION
• 00382902316503: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION

Maude Adverse Events

API? LISTERIA 10STRIPS+10MEDIA	BIOMERIEUX, SA	2020-03-26
API? RAPID ID 32 STREP	BIOMERIEUX SA	2019-11-22
API? 20 STREP STRIPS	BIOMERIEUX, SA	2019-11-08
API? 20 E 25 STRIPS	BIOMERIEUX, SA	2019-11-07
API? NH TEST STRIP	BIOMERIEUX, SA	2019-02-15
API? 20 STREP	BIOMERIEUX, SA	2018-11-19
BD BBL? DRYSLIDE? PYR KIT	BD CARIBE, LTD	2018-08-13
API? RAPID ID 32 STREP	BIOMERIEUX SA	2018-04-20
API? RAPID ID 32 STREP	BIOMERIEUX, SA	2017-12-21
API? RAPID ID 32 STREP	BIOMERIEUX, SA	2017-12-21
API? NH TEST STRIP	BIOMERIEUX SA	2017-10-05
API? NIN-2	BIOMERIEUX, SA	2017-08-28
VITEK? 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT	BIOMERIEUX, INC	2017-06-22
VITEK? 2 GN TEST KIT	BIOMERIEUX, INC	2017-06-01
VITEK? 2 GN TEST KIT	BIOMERIEUX, INC	2017-05-22
VITEK? 2 GN TEST KIT	BIOMERIEUX, INC	2017-05-22
VITEK? 2 NH TEST KIT	BIOMERIEUX, INC	2017-05-16
VITEK? 2 NH TEST KIT	BIOMERIEUX, INC	2017-05-16
VITEK? 2 NH TEST KIT	BIOMERIEUX, INC	2017-05-08
VITEK? 2 NH TEST KIT	BIOMERIEUX, INC	2017-05-01
VITEK? 2 GRAM NEGATIVE (GN) TEST KIT	BIOMERIEUX, INC	2017-04-28
VITEK? 2 NH TEST KIT	BIOMERIEUX, INC	2017-04-27
VITEK 2 GN TEST KIT	BIOMERIEUX, INC	2017-04-20
VITEK? 2 NH TEST CARD	BIOMERIEUX, INC	2017-04-18
VITEK? 2 NH TEST CARD	BIOMERIEUX, INC	2017-04-13
VITEK? 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT	BIOMERIEUX, INC	2017-04-05
VITEK? 2 GN TEST KIT	BIOMERIEUX, INC	2017-04-04
VITEK? 2 GN TEST KIT	BIOMERIEUX, INC	2017-03-29
VITEK? 2 NH TEST KIT	BIOMERIEUX, INC	2017-03-17
VITEK? 2 GN TEST KIT	BIOMERIEUX, INC	2017-03-13
VITEK? 2 GN TEST KIT	BIOMERIEUX, INC	2017-03-08
VITEK? 2 GN TEST KIT	BIOMERIEUX, INC	2017-03-07
VITEK? 2 GN TEST KIT	BIOMERIEUX, INC	2017-03-07
VITEK? 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT	BIOMERIEUX, INC	2017-03-03
VITEK? 2 GRAM NEGATIVE (GN) TEST KIT	BIOMERIEUX, INC	2017-03-01
VITEK? 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT	BIOMERIEUX, INC	2017-03-01
VITEK? 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT	BIOMERIEUX, INC	2017-02-28
VITEK? 2 GN TEST KIT	BIOMERIEUX, INC	2017-02-23
VITEK? 2 NH TEST KIT	BIOMERIEUX, INC	2017-02-07
VITEK? 2 GN ID TEST KIT	BIOMERIEUX, INC	2017-01-31
VITEK? 2 GN TEST KIT	BIOMERIEUX, INC	2017-01-24
VITEK? 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT	BIOMERIEUX, INC	2017-01-23
VITEK? 2 GN ID TEST KIT	BIOMERIEUX, INC	2017-01-23
VITEK? 2 GN ID TEST KIT	BIOMERIEUX, INC	2017-01-23
VITEK? 2 GN ID TEST KIT	BIOMERIEUX, INC	2017-01-20
VITEK? 2 GRAM NEGATIVE (GN) TEST KIT	BIOMERIEUX, INC	2017-01-20
VITEK? 2 GN ID TEST KIT	BIOMERIEUX, INC	2017-01-18
VITEK? 2 GN TEST KIT	BIOMERIEUX, INC	2017-01-06
VITEK? 2 GRAM NEGATIVE TEST KIT	BIOMERIEUX, INC	2017-01-06
VITEK? 2 GN TEST KIT	BIOMERIEUX, INC	2017-01-05