VFE VE-98

GUDID 08600000686048

EIA-VON WILLEBR.

Ramco Laboratories, Inc.

Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA)
Primary Device ID08600000686048
NIH Device Record Keyf15f14a2-6149-4452-ae91-f76b6cc8145f
Commercial Distribution StatusIn Commercial Distribution
Brand NameVFE
Version Model NumberVE-98
Catalog NumberVE-98
Company DUNS082013897
Company NameRamco Laboratories, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(281)313-1200
Emailramcolab@aol.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108600000686048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GGPTEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-03
Device Publish Date2019-03-26

Devices Manufactured by Ramco Laboratories, Inc.

08600000686031 - TfR2019-04-03 ELISA- TfR
08600000686048 - VFE2019-04-03EIA-VON WILLEBR.
08600000686048 - VFE2019-04-03 EIA-VON WILLEBR.
18600000686021 - Cand-Tec2019-04-03 Candida Detection
28600000686028 - Cand-Tec2019-04-03 Candida Detection
78600000686023 - Cand-Tec2019-04-03 Candida Detection
08600000686017 - Spectro Ferritin MT2019-04-01 ELISA-ferritin
08600000686024 - Cand-Tec2019-04-01 Candida Detection

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