FDA.reportPublic FDA data

Autokit Micro Albumin

Primary DI
04987481164666
Brand
Autokit Micro Albumin
Company
FUJIFILM WAKO PURE CHEMICAL CORPORATION
Model
999-06001
Catalog number
999-06001
Device description
In-Vitro Diagnostic Use
Published
2021-07-30
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
JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030320000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030320000WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SETWako Chemicals USA, Inc.2003-04-11JIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987481164666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987481164666049874811646664987481164666

GMDN Terms#

Term, Definition table
TermDefinition
Albumin IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of albumin in a clinical specimen, using a nephelometry/turbidimetry method.

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
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
14987481164601HR Series NEFA-HR(2) Color Reagent A999-34691999-346912021-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740190316ARCHITECTABBOTT IRELANDJIQ2022-05-25
00380740190781AlinityABBOTT IRELANDJIQ2022-02-28
00192024031143Ricca Chemical Company®Ricca Chemical Company, LLCJIQ2021-02-04
00192024031150Ricca Chemical Company®Ricca Chemical Company, LLCJIQ2021-02-04
00192024068545Ricca Chemical Company®Ricca Chemical Company, LLCJIQ2021-02-04
00192024068552Ricca Chemical Company®Ricca Chemical Company, LLCJIQ2021-02-04
03610230008621Yumizen C1200 Urinary ProteinsHORIBA ABX SASJIQ2020-09-09
00380740135201AlinityAbbott GmbHJIQ2018-08-31
00380740119416ARCHITECTAbbott GmbHJIQ2017-01-31
00380740119393ARCHITECTAbbott GmbHJIQ2016-12-31
00380740119409ARCHITECTAbbott GmbHJIQ2016-12-31
05060500090005Synermed®INFRARED LABORATORY SYSTEMS LLCJIQ2016-09-20
00380740003630ARCHITECTABBOTT LABORATORIESJIQ2016-09-09
00380740003647ARCHITECTABBOTT LABORATORIESJIQ2016-09-09
00380740003654ARCHITECTABBOTT LABORATORIESJIQ2016-09-09
15099590180164IMMAGE Beckman Coulter, Inc.JIQ2016-08-24
03610230005057ABX PENTRA URINARY PROTEINS CPHORIBA ABX SASJIQ2016-08-23