FDA.reportPublic FDA data

Streptex 200

Primary DI
05056080501383
Brand
Streptex 200
Company
REMEL EUROPE LIMITED
Model
R30164701
Published
2021-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JTODiscs, Strips And Reagents, Microorganism Differentiation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTODiscs, Strips And Reagents, Microorganism DifferentiationMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K842828000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K842828000STREPTEX ZL01Wellcome Diagnostics1984-08-15JTO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056080501383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056080501383050560805013835056080501383

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Streptococcus serological grouping IVD, kit, agglutinationA collection of reagents and other associated materials intended to be used to determine the serological group (or Lancefield group) of beta-haemolytic streptococci isolated from a clinical specimen by culture, using an agglutination method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401256694238microbiology.techsupport.uk@thermofisher.com

Regulatory Flags#

DUNS number
232600853
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056080500928Shigella boydii polyvalent 1 (1-6) Agglutinating SerumR301639012026-05-05
05056080501024NAR301650012016-12-09
05056080501888Wellcolex E.coli O157R309595012021-07-21
05056080501598Proteus OX2 Agglutinating SerumR301657012021-07-21
05056080500065NAR308550012016-09-24
05056080500126NAR308553012016-09-24
05056080500317NAR309577012016-09-24
05056080500324NAR309578012016-09-24
05056080500331NAR309579012016-09-24
05056080500348NAR309580012016-09-24
05056080500379NAR309583012016-09-24
05056080500409NAR309586012016-09-24
05056080500591NAR301606012016-09-24
05056080500607NAR301607012016-09-24
05056080500614NAR301608012016-09-24
05056080500638NAR301610012016-09-24
05056080500645NAR301611012016-09-24
05056080500652NAR301612012016-09-24
05056080500713NAR301618012016-09-24
05056080500768NAR301623012016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848838059865^BM^ PK/50 OXIDASE TESTREMEL, INC.JTO2026-01-16
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00816576025121N/AHARDY DIAGNOSTICSJTO2024-01-08
00819398021586N/AHARDY DIAGNOSTICSJTO2024-01-08
00810144911229RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911236RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911243RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911250RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911267RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911274RediporAnalytiChem USA, Inc.JTO2023-09-21
00810144911281RediporAnalytiChem USA, Inc.JTO2023-09-21
00816576029136HardyDisk™HARDY DIAGNOSTICSJTO2023-04-26
00816576029129HardyDisk™HARDY DIAGNOSTICSJTO2023-04-26
00848838002106REMELREMEL, INC.JTO2023-01-03
00848838004131REMELREMEL, INC.JTO2023-01-03
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00848838022395REMELREMEL, INC.JTO2023-01-03
00848838022517REMELREMEL, INC.JTO2023-01-03
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00848838022616REMELREMEL, INC.JTO2023-01-03
00848838022630REMELREMEL, INC.JTO2023-01-03
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00848838022821REMELREMEL, INC.JTO2023-01-03