TPHA Screen 0066826

GUDID 10888234001485

TPHA Screen is used in the qualitative screening of blood donors for the detection of IgG and IgM antibodies to Treponema pallidum in human serum and

IMMUCOR, INC.

Treponema pallidum total antibody IVD, kit, agglutination
Primary Device ID10888234001485
NIH Device Record Key64a52ad9-874c-42fe-9dd3-00c8f863ebcf
Commercial Distribution StatusIn Commercial Distribution
Brand NameTPHA Screen
Version Model Number0066826
Catalog Number0066826
Company DUNS061446282
Company NameIMMUCOR, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-466-8267
Emailtech_support@immucor.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234001485 [Primary]

FDA Product Code

MYRTest,Donor,Syphilis,Antigens,Treponemal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-04-15

Devices Manufactured by IMMUCOR, INC.

10888234001546 - Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum2022-09-12 Immucor’s Capture-R Positive Control Serum (Weak) and Capture-R Negative Control Serum are run controls to be used in Capture-
10888234001553 - Capture-R Select2022-09-12 The Capture-R Select Solid Phase System provides modified microwells for the immobilization of human erythrocytes for use in sol
10888234001560 - Capture-P2022-09-12 Capture-P Solid Phase System is intended for use in the detection of antibodies to platelets. Capture-P Solid Phase System is de
10888234001577 - Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum2022-09-12 Immucor’s Capture-P Positive Control Serum (Weak) and Capture-P Negative Control Serum are run controls to be used in the Capt
10888234002291 - Capture LISS2022-09-12 Capture LISS is a low ionic solution containing glycine and the dye Bromocresol Purple and the preservative sodium azide (0.1%).
10888234002307 - Capture-R Ready Indicator Red Cells2022-09-12 Anti-IgG-coated Indicator Red Cells for use in Capture-R Ready-Screen, Capture-R Ready-ID or Capture-R Select Solid Phase Assays
10888234002314 - Capture-P Indicator Red Cells2022-09-12 Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Capture-P Ready-Screen solid phase assays for the dete
10888234001522 - Referencells2022-08-11 Referencells (Pooled Cells) are intended for use in tube and microplate ABO serum grouping tests.

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