FDA.reportPublic FDA data

Autoscreen I MS KDY/STM 48 Test

Primary DI
00813545021986
Brand
Autoscreen I MS KDY/STM 48 Test
Company
SCIMEDX CORPORATION
Model
1248L
Catalog number
1248L
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, ControlImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813545021986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813545021986008135450219868135450219860813545021986

GMDN Terms#

Term, Definition table
TermDefinition
Parietal cell antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to parietal cells in a clinical specimen, using a fluorescent immunoassay method.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002215598service@scimedx.com

Regulatory Flags#

DUNS number
155424708
Device count
1
DM exempt
false
Premarket exempt
true
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
00813545026905MeDiCa1001-481001-482020-11-04
00813545026912MeDiCa1001-961001-962020-11-04
00813545023843ProSorb-G 2 ml 50 TestCB004CB0042023-06-13
00813545029029GBM IgG Test SystemGBM396GBM3962023-06-13
00813545029036MBO IgG Test SystemMBO396MBO3962023-06-13
00813545029043PR3 IgG Test SystemPR3396PR33962023-06-13
00813545026561MeDiCa010101012020-12-01
00813545026578MeDiCa010201022020-12-01
00813545026585MeDiCa020102012020-12-01
00813545026592MeDiCa020202022020-12-01
00813545026608MeDiCa030103012020-12-01
00813545026615MeDiCa030203022020-12-01
00813545026622MeDiCa0301-M0301-M2020-12-01
00813545026639MeDiCa0302-M0302-M2020-12-01
00813545026646MeDiCa040104012020-12-01
00813545026653MeDiCa040204022020-12-01
00813545026660MeDiCa0401-M0401-M2020-12-01
00813545026677MeDiCa0402-M0402-M2020-12-01
00813545026684MeDiCa0604-ES0604-ES2020-12-01
00813545026691MeDiCa0608-ES0608-ES2020-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813545029029GBM IgG Test SystemSCIMEDX CORPORATIONDBL2023-06-13
00813545026684MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026691MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026776MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026783MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026790MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026806MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026813MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026820MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026837MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026844MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026851MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026868MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026875MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026882MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545026899MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027124MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027131MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027223MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027261MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027278MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027285MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027292MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027308MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027315MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027322MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027339MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027346MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027353MeDiCaSCIMEDX CORPORATIONDBL2020-12-01
00813545027360MeDiCaSCIMEDX CORPORATIONDBL2020-12-01