MicroTest M4RT

Primary DI
00842558109527
Brand
MicroTest M4RT
Company
REMEL, INC.
Model
R12705
Catalog number
R12705
Device description
M4RT(3ml) w/o BEADS NP Swab Kit 100/pk
Published
2022-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K965152000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K965152000A.C.T. IIRemel Co.1997-01-22JSM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842558109527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842558109527008425581095278425581095270842558109527

GMDN Terms#

Term, Definition table
TermDefinition
Microbiological transport medium IVDA medium in powder, liquid, broth or gel form, commonly available in a tub or bottle from which aliquots can be prepared, intended to be used to maintain the viability of microorganisms suspected of being present in a clinical specimen during its transport prior to in vitro diagnostic analysis and/or culture. It has a non-nutritive composition with or without indicator and may include types such as Amies, anaerobic, Carey-Blair, Stuart, and viral transport/inactivation mediums. This device is not a specimen collection tube/container (i.e., is not intended to directly accept a specimen), and does not include patient-contact specimen sampling/extraction devices such as swabs/brushes.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
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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