FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740000202
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
1E01-21
Catalog number
01E0121
Device description
Immunoglobulin M
Published
2016-06-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DFTIGM, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DFTIgm, Antigen, Antiserum, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740000202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740000202003807400002023807400002020380740000202

GMDN Terms#

Term, Definition table
TermDefinition
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin M (IgM total) in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
00380740019730ARCHITECT9D96-2109D96212016-06-06
00380740225742ARCHITECT08G983008G98302026-10-14
00380740225759ARCHITECT04J623004J62302026-10-14
00380740019747ARCHITECT9D97-2109D97212016-06-06
00380740019761ARCHITECT9D99-2109D99212016-06-06
00380740138738ARCHITECT6P30-2106P30212016-09-09
00380740225575ARCHITECT04P553104P55312026-08-22
00380740138783Alinity09P710109P71012023-11-16
00380740136963Alinity07P810407P81042023-11-16
00380740136994Alinity07P830107P83012023-11-16
00380740137007Alinity07P800407P80042023-11-16
00380740137021Alinity07P790407P79042023-11-16
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740169916AlinityABBOTT IRELANDDFT2021-04-29
00380740169923ARCHITECTABBOTT IRELANDDFT2021-04-02
00380740175115ARCHITECTAbbott GmbHDFT2020-11-06
03610230007365Yumizen C1200 Immunoglobulin MHORIBA ABX SASDFT2020-07-13
00380740150693AlinityAbbott GmbHDFT2019-07-08
05055273204001IgMRANDOX LABORATORIES LIMITEDDFT2016-09-24
05055273204025IgMRANDOX LABORATORIES LIMITEDDFT2016-09-24
M52594000ImmunoFix ControlsHELENA LABORATORIES CORPORATIONDFT2016-09-07