FDA.reportPublic FDA data

Autokit CH50

Primary DI
00498748116440
Brand
Autokit CH50
Company
FUJIFILM WAKO PURE CHEMICAL CORPORATION
Model
995-40801
Catalog number
995-40801
Device description
In-Vitro Diagnostic Use
Published
2020-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DAEComplement C9, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DAEComplement C9, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954145000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954145000WAKO AUTOKIT CH50Wako Chemicals USA, Inc.1995-12-18DAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856626006113PreviousGS10
00498748116440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856626006113008566260061138566260061130856626006113
00498748116440004987481164404987481164400498748116440

GMDN Terms#

Term, Definition table
TermDefinition
Total complement activity (CH50) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total complement activity (CH50 ) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-323-5300fmsuregulatoryaffairs@fujifilm.com

Regulatory Flags#

DUNS number
690598875
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987481164666Autokit Micro Albumin999-06001999-060012021-07-30
04987481164673Autokit Micro Albumin Control Set991-06201991-062012021-06-01
14987481164427uTASWako Chip Cassette993-61601993-616012020-10-23
14987481164465uTASWako AFP-L3 Sample Dilution Buffer997-61501997-615012020-10-23
10856626006080uTASWako Chip Cassette993-61601993-616012016-11-11
10856626006189uTASWako AFP-L3 Sample Dilution Buffer997-61501997-615012016-12-22
04987481164680uTASWako i30991-60301991-603012020-10-23
00856626006229uTASWako i30991-60301991-603012020-06-01
14987481164557HDL-C/LDL-C Calibrator990-28011990-280112020-10-23
14987481164564L-Type HDL-C Reagent 1991-00101991-001012020-10-23
14987481164571L-Type HDL-C Reagent 2997-00201997-002012020-10-23
14987481164588L-Type HDL-C Reagent 1997-72591997-725912020-10-23
14987481164595L-Type HDL-C Reagent 2993-72691993-726912020-10-23
10856626006035HDL-C/LDL-C Calibrator990-28011990-280112016-12-07
10856626006042L-Type HDL-C (Reagent 1) 991-00101991-001012016-11-11
10856626006097L-Type HDL-C Reagent 2993-72691993-726912016-11-23
10856626006141L-Type HDL-C (Reagent 2)997-00201997-002012016-11-11
10856626006196L-Type HDL-C Reagent 1997-72591997-725912016-11-23
14987481164533L-Type LDL-C Reagent 1999-00404999-004042021-06-01
14987481164540L-Type LDL-C Reagent 2999-00504999-005042021-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051700021098Optilite® CH50 ReagentTHE BINDING SITE GROUP LIMITEDDAE2024-11-20
04987481164406Autokit CH50FUJIFILM WAKO PURE CHEMICAL CORPORATIONDAE2020-10-23
04987481164512CH50 CalibratorFUJIFILM WAKO PURE CHEMICAL CORPORATIONDAE2020-10-23
00856626006151CH50 CalibratorFUJIFILM WAKO PURE CHEMICAL CORPORATIONDAE2016-12-07
00856626006113Autokit CH50FUJIFILM WAKO PURE CHEMICAL CORPORATIONDAE2016-11-11
05051700010269Total Haemolytic Complement THE BINDING SITE GROUP LIMITEDDAE2016-09-24
05051700010276Total Haemolytic Complement THE BINDING SITE GROUP LIMITEDDAE2016-09-24
05051700010283Total Haemolytic Complement THE BINDING SITE GROUP LIMITEDDAE2016-09-24
05051700012294CH50 Eq Enzyme Immunoassay KitTHE BINDING SITE GROUP LIMITEDDAE2016-09-24
05051700015592Human CH50 Reagent pack for use on the SPAPLUSTHE BINDING SITE GROUP LIMITEDDAE2016-09-24
05051700018210Optilite CH50 ReagentTHE BINDING SITE GROUP LIMITEDDAE2016-09-24
30014613335566MicroVueQUIDEL CORPORATIONDAE2016-09-15