FDA.reportPublic FDA data

RAMP® 200 CM Control Module

Primary DI
10627966005237
Brand
RAMP® 200 CM Control Module
Company
Response Biomedical Corp
Model
C2100
Catalog number
C2100
Device description
RAMP® 200 Control Module manages the sample test results that it receives from the Test Module.
Published
2017-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KHOFluorometer, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHOFluorometer, For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071591000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071591000RAMP INFLUENZA A/B ASSAYResponse Biomedical Corp.2008-04-16PSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10627966005237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1062796600523710627966005237

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescent immunoassay analyser IVD, point-of-careA portable, electrically-powered instrument typically used to scan an immunoassay reagent vehicle (e.g., test strip, cassette, or card) after exposure to a clinical specimen, to provide a quantitative, semi-quantitative, and/or qualitative in vitro determination of chemical substances and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from the immunological reaction between the reagents and the specimen. It is mostly used for rapid in vitro diagnostic measurements at the point-of-care and in the laboratory.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight1Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1.888.525.7267customersupport@responsebio.com

Regulatory Flags#

DUNS number
248609018
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10627966005176RAMP® Flu A + B TEST KIT; 25 TESTSC1107C11072017-08-31
10627966005183RAMP® RSV TEST KIT; 25 TESTSC1108C11082017-08-31
10627966005190RAMP® Flu A + B Control SwabsC1135C11352017-08-31
10627966005206RAMP® RSV Control SwabsC1136C11362017-08-31
10627966005244RAMP® 200 TM Test ModuleC3100C31002017-08-31
10627966005008RAMP® Troponin I TEST KIT; 25 TESTSC1101C11012016-09-05
10627966005015RAMP® CK-MB TEST KIT; 25 TESTSC1102C11022016-09-05
10627966005022RAMP® Myoglobin TEST KIT; 25 TESTSC1103C11032016-09-05
10627966005046RAMP® NT-proBNP TEST KIT; 25 TESTSC1105C11052016-09-15
10627966005077RAMP® CARDIAC CONTROLS; LEVEL 1 C2003-1C2003-12017-08-31
10627966005084RAMP® CARDIAC CONTROLS; LEVEL 2C2003-2C2003-22017-08-31
10627966005091RAMP® CARDIAC CONTROLS; LEVEL 3C2003-3C2003-32017-08-31
10627966005220RAMP® 1 Clinical Reader SystemC1100C11002017-08-31
10627966005299RAMP® Cardiac Controls - Level 1C5003-1C5003-12019-12-20
10627966005305RAMP® Cardiac Controls - Level 2C5003-2C5003-22019-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850076346010HealgenHEALGEN LIFE SCIENCE, LLCKHO2026-02-06
10850076346017HealgenHEALGEN LIFE SCIENCE, LLCKHO2026-02-06
05430003908761SEEKER®Lacar MDX TechnologiesKHO2026-01-15
07649996894014abioSCOPEAbionic SAKHO2025-02-18
06974849369380Macro & Micro-Test Fluorescence Immunoassay AnalyzerJiangsu Macro & Micro-Test Med-Tech Co., Ltd.KHO2024-09-19
06974849369397Macro & Micro-Test Fluorescence Immunoassay AnalyzerJiangsu Macro & Micro-Test Med-Tech Co., Ltd.KHO2024-09-19
08809317541259FREND SystemNanoEnTek, Inc.KHO2024-06-30
08800066300104ASFA® SCANNERMBD CO., Ltd.KHO2023-11-21
06974521002246Superbio Immunofluorescence AnalyzerShenzhen Superbio Technology Co., Ltd.KHO2023-03-22
06974521006626Bioeasy Immunofluorescence AnalyzerShenzhen Superbio Technology Co., Ltd.KHO2023-03-22
00817302022339Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYANCAROLINA LIQUID CHEMISTRIES CORPORATIONKHO2023-03-10
06974849369298Immunofluorescence ReaderJiangsu Macro & Micro-Test Med-Tech Co., Ltd.KHO2022-12-06
06438147335008AutoDELFIA Automatic Immunoassay SystemWallac OyKHO2022-08-11
06438147335022AutoDELFIA Automatic Immunoassay SystemWallac OyKHO2022-08-11
09120052070521INFINITE 200 PROTecan Austria GmbHKHO2021-06-22
04897078440045ALiA FIA AnalyserSANWA BIOTECH LIMITEDKHO2021-01-27
04897078440052Ariel Fluorescent Immunoassay SystemSANWA BIOTECH LIMITEDKHO2021-01-27
04897078440106Thetis Fluorescent Immunoassay SystemSANWA BIOTECH LIMITEDKHO2021-01-27
30014613336341SofiaQUIDEL CORPORATIONKHO2020-10-21
30014613336648SofiaQUIDEL CORPORATIONKHO2020-10-21
10758750000272VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KHO2020-07-31
10758750001040VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KHO2020-07-31
10758750011308VITROSORTHO-CLINICAL DIAGNOSTICS, INC.KHO2020-07-31
06970136030100NAGuangzhou Labsim Biotech Co., LtdKHO2020-05-20
06970136030216NAGuangzhou Labsim Biotech Co., LtdKHO2020-05-20
08800066300005ASFA SCANNERMBD CO., Ltd.KHO2020-01-29
04560189282896AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360TOSOH CORPORATIONKHO2019-09-02
04560189283992AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900TOSOH CORPORATIONKHO2019-09-02
045601892840059tray SorterTOSOH CORPORATIONKHO2019-09-02
0456018928401219tray SorterTOSOH CORPORATIONKHO2019-09-02