FDA.reportPublic FDA data

CEDIA Phencyclidine (PCP) Assay

Primary DI
00884883004276
Brand
CEDIA Phencyclidine (PCP) Assay
Company
Microgenics Corporation
Model
100173
Published
2016-09-12
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

Product Codes#

Code, Name table
CodeName
LCMEnzyme Immunoassay, Phencyclidine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCMEnzyme Immunoassay, PhencyclidineUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884883004276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884883004276008848830042768848830042760884883004276

GMDN Terms#

Term, Definition table
TermDefinition
Phencyclidine (PCP) IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of phencyclidine (PCP) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122153799
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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

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00884883009318MAS Omni•IMMUNE Max, Level 2OIMM-2022025-08-12
00884883009325MAS Omni•IMMUNE Max, Level 3OIMM-3032025-08-12
00884883009332MAS Omni•IMMUNE Max, Sample PackOIMM-SP2025-08-12
00884883009349MAS Omni•IMMUNE PRO Max, Level 1OPROM-1012025-08-12
00884883009356MAS Omni•IMMUNE PRO Max, Level 2OPROM-2022025-08-12
00884883009363MAS Omni•IMMUNE PRO Max, Level 3OPROM-3032025-08-12
00884883009370MAS Omni•IMMUNE PRO Max, Sample PackOPROM-SP2025-08-12
00884883009257MAS OmniCORE Max, Level 1OCRM-1012025-06-27
00884883009264MAS OmniCORE Max, Level 2OCRM-2022025-06-27
00884883009271MAS OmniCORE Max, Level 3OCRM-3032025-06-27
00884883009288MAS OmniCORE Max, Sample PackOCRM-SP2025-06-27
00884883009219MAS Omni-Core II Liquid Assayed Integrated Chemistry Control 1OCRL-1012025-01-31
00884883009226MAS Omni-Core II Liquid Assayed Integrated Chemistry Control 2OCRL-2022025-01-31
00884883009233MAS Omni-Core II Liquid Assayed Integrated Chemistry Control 3OCRL-3032025-01-31
00884883009240MAS Omni-Core II Liquid Assayed Integrated Chemistry Control Sample PackOCRL-SP2025-01-31
00884883008830MAS Diabetes Max-SP (Sample-Pack)B400006882024-05-21
00884883008823MAS Diabetes Max, Multi-packB400006872024-05-20
00884883006027Acrometrix BB NAT HBV Positive Control9636032022-10-07
00884883007376MAS omni Infectious BSI Positive Control Panel for use with Siemens Assays10027480-U2021-11-03

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