FDA.reportPublic FDA data

NA

Primary DI
00848838091834
Brand
NA
Company
REMEL, INC.
Model
7116-70
Device description
MYCO PZA KIT
Published
2016-12-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJASusceptibility Test Powders, Antimycobacterial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJASusceptibility Test Powders, AntimycobacterialMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052323000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052323000VERSATREK MYCO PZA KITTrek Diagnostic Systems, Inc.2006-01-19MJA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848838091834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838091834008488380918348488380918340848838091834

GMDN Terms#

Term, Definition table
TermDefinition
Anti-tuberculosis (anti-TB) drug susceptibility testing reagent kit IVDA collection of reagents and other associated materials intended to be added to a culture medium containing a culture isolate of Mycobacteruim tuberculosis from a clinical specimen, to determine antimicrobial susceptibility to an anti-tuberculosis drug [e.g., pyrazinamide (PZA)].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8002556730ITechnicalSupport@remel.com
8002556730csemail@thermofisher.com

Regulatory Flags#

DUNS number
065769564
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848838018855NACP114-102016-09-24
00848838031274REMELR40041R400412023-01-03
00842558116709Spectra™ Candida Agar R018332026-02-09
00848838072772MicroTest M6R12582R125822022-12-22
00848838074844MicroTest M4RTR12567R125672022-12-22
00848838075018MicroTest M6R12560R125602022-12-22
00848838091827NA7115-602022-04-21
00848838091742VersaTREK™ VersaTREK™ Myco Streptomycin, 7120-302025-01-16
00848838003158Strep Selective II AgarR018592026-01-16
00848838059865^BM^ PK/50 OXIDASE TESTR90556352026-01-16
00848838066856Liquid Amies,Dual Swab PK/50R7230952025-06-18
00848838066887Liquid Stuarts,Single Swab PK/500R7231102025-06-18
00848838066894Liquid Stuarts,Single Swab PK/50R7231152025-06-18
00848838066900Liquid Stuarts,Dual Swab PK/500R7231202025-06-18
00848838066917Liquid Stuarts,Dual Swab PK/50R7231252025-06-18
00848838066924Liquid Stuarts,Wire Shaft Swab PK/100R7231302025-06-18
00848838066931Liquid Stuarts,Wire Shaft PK/50R7231352025-06-18
00848838011177Sensititre Demineralized WaterT33392023-12-21
00842558105611^CE^Liq Stuarts,Dual Swab 36mmPK/500r97231202025-10-02
00842558116402BactiSwab Dry PK/100R7231352025-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30382902451151BD BACTEC™ MGIT™ 960 PZA MediumBECTON, DICKINSON AND COMPANYMJA2016-05-19
00382902451235BD BACTEC™ MGIT™ 960 SIRE KitBECTON, DICKINSON AND COMPANYMJA2016-05-19
00382902451259BD BACTEC™ MGIT™ 960 STR 4.0 KitBECTON, DICKINSON AND COMPANYMJA2016-05-19
00382902451266BD BACTEC™ MGIT™ 960 INH 0.4 KitBECTON, DICKINSON AND COMPANYMJA2016-05-19
00382902451280BD BACTEC™ MGIT™ 960 PZA KitBECTON, DICKINSON AND COMPANYMJA2016-05-19
00382902451570BD BACTEC™ MGIT™ 960 IR KitBECTON, DICKINSON AND COMPANYMJA2016-05-19