MicroTest M4RT

Primary DI
00842558111209
Brand
MicroTest M4RT
Company
Remel Inc.
Model
R12950
Catalog number
R12950
Device description
M4RT(3ml) w/o Beads PK/50
Published
2023-01-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941579000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941579000MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5)Microtest1994-10-21JSM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842558111209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842558111209008425581112098425581112090842558111209

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118161628
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848838018510R12576 M4RTUniversal Plus Swab Kit PK/100R12576 2024-03-29
00842558112602MicroTest M4RTR12952R129522023-01-05
00842558109718MicroTest M4RTR12900R129002023-01-05
00842558110202MicroTest M4RTR12901R129012023-01-05
00848838078132MicroTestR12533R125332023-01-05
00842558116501BactiSwab (Dry) CS/500R1201702024-08-14